FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL PRODUCTS, SKIN STAPLE REMOVER
K Number: K822963
·
Decision Nov 8, 1982
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
5
Applicant Total
3
Review Days
34
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Basic Information
- Device Name
- SURGICAL PRODUCTS, SKIN STAPLE REMOVER
- K Number
- K822963
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4320
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Temp-Stik Corp.
- Date Received
- October 5, 1982
- Decision Date
- November 8, 1982
- Product Code
- FZQ
- 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 |
|---|---|---|---|
| FZQ | Clip, Removable (Skin) | FDA class 1 | General, Plastic Surgery |
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