FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BYPASS LEG POSITIONER
K Number: K932186
·
Decision Jun 1, 1993
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
34
Applicant Total
5
Review Days
27
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Basic Information
- Device Name
- BYPASS LEG POSITIONER
- K Number
- K932186
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Voss Medical Products
- Date Received
- May 5, 1993
- Decision Date
- June 1, 1993
- Product Code
- FQO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FQO | Table, Operating-Room, Ac-Powered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Voss Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K932187 | PRONE POSITIONER | Jun 1, 1993 | Substantially Equivalent |
| K896338 | VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA | May 17, 1990 | Substantially Equivalent |
| K885161 | VOSS VEIN CLAMP | Dec 22, 1989 | Substantially Equivalent |
| K895369 | VOSS GRAFT MARKER | Sep 27, 1989 | Substantially Equivalent |