FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE MAGNUM CHIN IMPLANT
K Number: K902285
·
Decision Sep 12, 1990
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
65
Applicant Total
7
Review Days
113
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Basic Information
- Device Name
- THE MAGNUM CHIN IMPLANT
- K Number
- K902285
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3550
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Applied Biomaterial Technologies
- Date Received
- May 22, 1990
- Decision Date
- September 12, 1990
- 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 Applied Biomaterial Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K945552 | DURALASTIC SHEETING | Jan 31, 1995 | Substantially Equivalent |
| K935571 | DURALASTIC SHEETING | Jan 31, 1995 | Substantially Equivalent |
| K931500 | THE PERMARIDGE MATRIX CHIN | Nov 17, 1994 | Substantially Equivalent |
| K913768 | PEC IMPLANT | Feb 3, 1992 | Substantially Equivalent |
| K902284 | ZYMALAR IMPLANT | Sep 12, 1990 | Substantially Equivalent |
| K902283 | THE NAUTILUS NASAL IMPLANT | Aug 14, 1990 | Substantially Equivalent |