The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Probes, Various.
| Device ID | K841003 |
| 510k Number | K841003 |
| Device Name: | PROBES, VARIOUS |
| Classification | Surgical Instruments, G-u, Manual (and Accessories) |
| Applicant | PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. P.O. BOX 111 Norristown, PA 19401 |
| Contact | William J Frezel |
| Correspondent | William J Frezel PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. P.O. BOX 111 Norristown, PA 19401 |
| Product Code | KOA |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-09 |
| Decision Date | 1984-03-20 |