FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DURALASTIC ANATOMICAL CHIN IMPLANTS
K Number: K971478
·
Decision Jul 18, 1997
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
65
Applicant Total
9
Review Days
86
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Basic Information
- Device Name
- DURALASTIC ANATOMICAL CHIN IMPLANTS
- K Number
- K971478
- 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
- Allied Biomedical Corp.
- Date Received
- April 23, 1997
- Decision Date
- July 18, 1997
- 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 Allied Biomedical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K982051 | KELOCATE SHEETING | Aug 5, 1998 | Substantially Equivalent |
| K971481 | DURALASTIC ANATOMICAL NASAL IMPLANTS | Jul 18, 1997 | Substantially Equivalent |
| K971479 | DURALASTIC ANATOMICAL MALAR IMPLANTS | Jul 18, 1997 | Substantially Equivalent |
| K971480 | DURALASTIC I AND DURALASTIC II | May 28, 1997 | Substantially Equivalent |
| K955368 | DURALASTIC I | Feb 8, 1996 | Substantially Equivalent |
| K955370 | DURALASTIC II | Feb 8, 1996 | Substantially Equivalent |
| K955433 | DURALASTIC SILICONE TUBING | Jan 26, 1996 | Substantially Equivalent |
| K954413 | KELOCOTE | Nov 29, 1995 | Substantially Equivalent |