FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LOWER EXTREMITY SUPPORT SYSTEM-LESS
K Number: K810433
·
Decision Mar 13, 1981
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
60
Applicant Total
3
Review Days
22
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Basic Information
- Device Name
- LOWER EXTREMITY SUPPORT SYSTEM-LESS
- K Number
- K810433
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Walgen Medical Innoventions
- Date Received
- February 19, 1981
- Decision Date
- March 13, 1981
- Product Code
- FWZ
- 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 |
|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | FDA class 1 | General, Plastic Surgery |
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