FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN
K Number: K925610
·
Decision Nov 18, 1994
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
65
Applicant Total
24
Review Days
743
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Basic Information
- Device Name
- FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN
- K Number
- K925610
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3550
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microtek Medical, Inc.
- Date Received
- November 5, 1992
- Decision Date
- November 18, 1994
- Product Code
- FWP
- 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 |
|---|---|---|---|
| FWP | Prosthesis, Chin, Internal | FDA class 2 | General, Plastic Surgery |
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