The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Intrauterine Device Remover.
| Device ID | K842295 |
| 510k Number | K842295 |
| Device Name: | INTRAUTERINE DEVICE REMOVER |
| Classification | Remover, Intrauterine Device, Contraceptive, Hook-type |
| Applicant | PREMIER DENTAL PRODUCTS CO. P.O. BOX 111 Norristown, PA 19404 |
| Contact | William J Frezel |
| Correspondent | William J Frezel PREMIER DENTAL PRODUCTS CO. P.O. BOX 111 Norristown, PA 19404 |
| Product Code | HHF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-11 |
| Decision Date | 1984-10-12 |