FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOPSY PUNCH, SURGICAL
K Number: K933670
·
Decision Jan 7, 1994
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
2
Applicant Total
27
Review Days
163
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Basic Information
- Device Name
- BIOPSY PUNCH, SURGICAL
- K Number
- K933670
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Byron Medical
- Date Received
- July 28, 1993
- Decision Date
- January 7, 1994
- Product Code
- EME
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EME | Punch, Biopsy, Surgical | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EME), ordered by most recent decision date.
PULPDENT POLYAMIDE DENTIN LINER
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EURO-MED LIGHT TOUCH BIOPSY PUNCH
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| K974295 | BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING | Feb 10, 1998 | Substantially Equivalent |
| K973133 | BIG BAG 3000 PRESSURE INFUSOR | Sep 12, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K934179 | DISPOSABLE BAG DECANTER | May 23, 1994 | Substantially Equivalent |
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