BIOPSY PUNCH, VARIOUS
FDA 510(k) clearance K841008 · decided 1984-06-08
Clearance details
- K-number
- K841008
- Device name
- BIOPSY PUNCH, VARIOUS
- Applicant
- Premier Dental Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-03-09
- Decision date
- 1984-06-08
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- GEE
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, 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 |
|---|---|---|
| STERILE SOFT TISSUE BIOPSY NEEDLE (K854003) | Co-Medical, Inc. | 1985-10-18 |
| DEFLECTING CYTOLOGY BRUSH (K822490) | Van-Tec, Inc. | 1982-09-14 |
| STERILE CYTOLOGY BRUSHES (K820259) | American Endoscopy, Inc. | 1982-03-05 |
| WHISK-R (K812694) | Medi-Spec | 1981-10-26 |
| CAMLOC SYRINGE BIOPSY KIT (K801304) | Johannah Medical Services, Inc. | 1980-06-17 |
| TROTEX II SCREW NEEDLE BIOPSY INSTR. SET (K792316) | Ursus Konsult AB | 1979-12-18 |
Recalls involving this device
No recalls on record reference this clearance.