FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL VIDEO CAMERA, MODEL 9500
K Number: K902359
·
Decision Jul 12, 1990
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
5
Applicant Total
1
Review Days
44
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Basic Information
- Device Name
- SURGICAL VIDEO CAMERA, MODEL 9500
- K Number
- K902359
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Seitz Technical Products, Inc.
- Date Received
- May 29, 1990
- Decision Date
- July 12, 1990
- Product Code
- FWB
- 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 |
|---|---|---|---|
| FWB | Camera, Television, Surgical, Without Audio | FDA class 1 | General, Plastic Surgery |
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