FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHIN IMPLANT STYLE I
K Number: K945998
·
Decision Feb 7, 1995
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
65
Applicant Total
7
Review Days
69
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Basic Information
- Device Name
- CHIN IMPLANT STYLE I
- K Number
- K945998
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3550
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- King & Spalding
- Date Received
- November 30, 1994
- Decision Date
- February 7, 1995
- 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 King & Spalding
| K Number | Device Name | ||
|---|---|---|---|
| K942422 | PANASONIC WRIST BLOOD PRESSURE METER | Feb 15, 1995 | Substantially Equivalent |
| K942423 | NAIS WRIST BLOOD PRESSURE METER | Feb 15, 1995 | Substantially Equivalent |
| K944408 | IMPLANTECH MEDICAL GRADE SILICONE SHEETING | Nov 9, 1994 | Substantially Equivalent |
| K942421 | IMPLANTECH LATERAL MANDIBULAR BAR IMPLANT | Aug 8, 1994 | Substantially Equivalent |
| K942420 | IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT | Aug 8, 1994 | Substantially Equivalent |
| K941972 | HEMO-O-LOK | Jun 29, 1994 | Substantially Equivalent |