FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMPLIGREFFE
K Number: K830993
·
Decision May 3, 1983
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
11
Applicant Total
5
Review Days
35
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Basic Information
- Device Name
- AMPLIGREFFE
- K Number
- K830993
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Prothia USA, Inc.
- Date Received
- March 29, 1983
- Decision Date
- May 3, 1983
- Product Code
- GFD
- 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 |
|---|---|---|---|
| GFD | Dermatome | FDA class 1 | General, Plastic Surgery |
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