Medical Device Reporting Here are links to
FDA Final Rule Changes to 21 CFR parts, 803 and 804, effective March 27, 2000,
which is for Medical Device Reporting for Manufacturer Reporting, Importer
Reporting, User Facility Reporting, and Distributor Reporting.
http://www.fda.gov/ohrms/dockets98fr/012600c.txt
http://www.fda.gov/ohrms/dockets98fr/012600c.pdf
Changes of interest are:
- Device user facilities will submit an annual summary report
rather than the semi-annual summary report.
- Each report and its envelope shall be specifically identified,
e.g. "User Facility Report" "Annual Report" etc.
- User facilities, importers, and manufacturers shall establish
and maintain MDR event files.
- The front page of the FDA form 3500A is to be filled out by all
reporters within 30 days (originally 10 days) of becoming aware of information
that reasonably suggest that a device has or may have caused or contributed to
a death or serious injury.
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Mennen Medical Corporate Profile
Mennen Medical is the medical arm of the Charterhouse Group International, a
highly diversified conglomerate engaged in aquistion and management of
companies for over twenty years. Combining innovative thinking with the
significant financial resources, Charterhouse has developed a substantial
portfolio of 75 high quality companies which are leaders in a wide range of
industries including: hospital and physician pratice management, medical
devices, electronic components, internet services, computer hardware and
software, real estate development and consumer products. Mennen Medical has
three divisions: USA, Israel and France.
Charterhouse's vision for Mennen
Medical is to introduce a stream of new high tech products designed to meet the
evolving needs of healthcare providers. The strategic planning, financial
depth, limitless resources and long range consistency of Charterhouse is the
fuel for Mennen Medical in its ongoing efforts to develop innovative and
affordable solutions for today's healthcare needs.
Mennen strives to lead
the way in patient monitoring and lay claim to a number of industry firsts
including: Total Solid State Designs, Full-Color Patient Monitoring, Color
Computerized Cath Lab, Cath-Lab Systems w/Backup Mode, 7 Lead ST Segment
Analysis, and Info Card for Transport of Patient Data.
Source: www.mennenmedical.com |
Alternat Lamp Sources |
Robeck Co.
Specializing in MLA Coagulation
instruments
1101 11th Place South
Birmingham, AL 35205
www.robeckonline.com
E-mail:
bob@robeckonline.com
Voicemail:
(800)280-6545
Fax: (205)323-2882
Bulbtronics
(800)654-8542
ask for Medical Dept.
BBC Lighting &
Supply
Milwaukee, Wisconsin
Patty Kasica
www.bbclighting.com
E-mail:
bbc@execpc.com
Voicemail:
(800)533-0406 |
Alpha Source
Milwaukee, Wisconsin
(800)654-9845
Gray Supply
East Chicago, IN
(800)
TOP-BULB
US Technologies
Marlton, NJ
(800)958-2852
Atlas Specialty Lighting
7304 N. Florida Ave
Tampa, FL
33604
(800)338-5854
Fax: (813)238-6656
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