The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Iud Hooks - Simple, Universal And Sklar.
| Device ID | K891030 |
| 510k Number | K891030 |
| Device Name: | IUD HOOKS - SIMPLE, UNIVERSAL AND SKLAR |
| Classification | Remover, Intrauterine Device, Contraceptive, Hook-type |
| Applicant | ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
| Contact | Anna Straight |
| Correspondent | Anna Straight ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
| Product Code | HHF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-28 |
| Decision Date | 1989-03-17 |