The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Twin Balloon Injector.
| Device ID | K902975 |
| 510k Number | K902975 |
| Device Name: | TWIN BALLOON INJECTOR |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
| Contact | J Zinnanti |
| Correspondent | J Zinnanti ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-06 |
| Decision Date | 1990-09-26 |