FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STEREOMED CAMERA
K Number: K823534
·
Decision Dec 15, 1982
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
0
Applicant Total
1
Review Days
25
Basic Information
- Device Name
- STEREOMED CAMERA
- K Number
- K823534
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- DISEASES OF THE SKIN CLINIC, P.A.
- Date Received
- November 20, 1982
- Decision Date
- December 15, 1982
- Product Code
- FTT
- 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 |
|---|---|---|---|
| FTT | Camera, Still, Surgical | FDA class 1 | General, Plastic Surgery |