FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOPSY PUNCH
K Number: K896303
·
Decision Feb 13, 1990
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
6
Applicant Total
3
Review Days
106
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Basic Information
- Device Name
- BIOPSY PUNCH
- K Number
- K896303
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Premier Medical
- Date Received
- October 30, 1989
- Decision Date
- February 13, 1990
- Product Code
- LRY
- 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 |
|---|---|---|---|
| LRY | Punch, Surgical | FDA class 1 | General, Plastic Surgery |
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