BIOPSY PUNCH, SURGICAL
FDA 510(k) clearance K933670 · decided 1994-01-07
Clearance details
- K-number
- K933670
- Device name
- BIOPSY PUNCH, SURGICAL
- Applicant
- Byron Medical
- Decision
- Substantially Equivalent
- Date received
- 1993-07-28
- Decision date
- 1994-01-07
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- EME
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PULPDENT POLYAMIDE DENTIN LINER (K911285) | Pulpdent Corp. | 1991-10-09 |
| EURO-MED LIGHT TOUCH BIOPSY PUNCH (K884740) | Buckman Co., Inc. | 1989-03-06 |
Recalls involving this device
No recalls on record reference this clearance.