EURO-MED LIGHT TOUCH BIOPSY PUNCH
FDA 510(k) clearance K884740 · decided 1989-03-06
Clearance details
- K-number
- K884740
- Device name
- EURO-MED LIGHT TOUCH BIOPSY PUNCH
- Applicant
- Buckman Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-11-14
- Decision date
- 1989-03-06
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- EME
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Martinez, CA, 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 |
|---|---|---|
| BIOPSY PUNCH, SURGICAL (K933670) | Byron Medical | 1994-01-07 |
| PULPDENT POLYAMIDE DENTIN LINER (K911285) | Pulpdent Corp. | 1991-10-09 |
Recalls involving this device
No recalls on record reference this clearance.