The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Biopsy Punch, Various.
| Device ID | K841008 |
| 510k Number | K841008 |
| Device Name: | BIOPSY PUNCH, VARIOUS |
| Classification | Brush, Biopsy, General & Plastic Surgery |
| Applicant | PREMIER DENTAL PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEE |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-09 |
| Decision Date | 1984-06-08 |