FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROSTHESIS OR SURGICAL PADS
K Number: K851668
·
Decision Jun 4, 1985
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
16
Applicant Total
1
Review Days
42
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Basic Information
- Device Name
- PROSTHESIS OR SURGICAL PADS
- K Number
- K851668
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.3800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Virginia Hall, Inc.
- Date Received
- April 23, 1985
- Decision Date
- June 4, 1985
- Product Code
- GBI
- 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 |
|---|---|---|---|
| GBI | Material, External Aesthetic Restoration, Used With Adhesive | FDA class 1 | General, Plastic Surgery |
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