The following data is part of a premarket notification filed by Voss Medical Products with the FDA for Bypass Leg Positioner.
Device ID | K932186 |
510k Number | K932186 |
Device Name: | BYPASS LEG POSITIONER |
Classification | Table, Operating-room, Ac-powered |
Applicant | VOSS MEDICAL PRODUCTS 1920 N STREET,N.W. SUITE 650 Washington, DC 20036 |
Contact | Bruce Mackler |
Correspondent | Bruce Mackler VOSS MEDICAL PRODUCTS 1920 N STREET,N.W. SUITE 650 Washington, DC 20036 |
Product Code | FQO |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-05 |
Decision Date | 1993-06-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00811304020119 | K932186 | 000 |