FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
VERGE VIDEOMETER
K Number: K962148
·
Decision Dec 20, 1996
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
3
Applicant Total
1
Review Days
200
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Basic Information
- Device Name
- VERGE VIDEOMETER
- K Number
- K962148
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Verg, Inc.
- Date Received
- June 3, 1996
- Decision Date
- December 20, 1996
- Product Code
- FXN
- 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 |
|---|---|---|---|
| FXN | Tape, Camera, Surgical | FDA class 1 | General, Plastic Surgery |
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