FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CREAT BRAND WAGNER CHIN IMPLANT
K Number: K812210
·
Decision Sep 11, 1981
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
65
Applicant Total
6
Review Days
38
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Basic Information
- Device Name
- CREAT BRAND WAGNER CHIN IMPLANT
- K Number
- K812210
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3550
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Aesthetech Corp.
- Date Received
- August 4, 1981
- Decision Date
- September 11, 1981
- 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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Other Clearances by Aesthetech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K873940 | CREAT BRAND O-RISE GENERAL ASPIRATOR | Nov 25, 1987 | Substantially Equivalent |
| K873434 | CREAT BRAND MALAR IMPLANT | Sep 11, 1987 | Substantially Equivalent |
| K853189 | CREAT BRAND I/A PACK CREAT BRAND PHACO PACK | Sep 24, 1985 | Substantially Equivalent |
| K843678 | CREAT BRAND SKIN EXPANDER | Nov 6, 1984 | Substantially Equivalent |
| K841283 | DISPOSABLE SUCTION TUBING SET | Apr 24, 1984 | Substantially Equivalent |