The following data is part of a premarket notification filed by Proto-med, Inc. with the FDA for Emmett Iud Thread Retreiver.
| Device ID | K820115 |
| 510k Number | K820115 |
| Device Name: | EMMETT IUD THREAD RETREIVER |
| Classification | Remover, Intrauterine Device, Contraceptive, Hook-type |
| Applicant | PROTO-MED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HHF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-18 |
| Decision Date | 1982-02-05 |