FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOPSY PUNCH, VARIOUS
K Number: K841008
·
Decision Jun 8, 1984
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
6
Applicant Total
41
Review Days
91
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Basic Information
- Device Name
- BIOPSY PUNCH, VARIOUS
- K Number
- K841008
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Premier Dental Products Co.
- Date Received
- March 9, 1984
- Decision Date
- June 8, 1984
- Product Code
- GEE
- 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 |
|---|---|---|---|
| GEE | Brush, Biopsy, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
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