The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Uterine Injector With Spring.
| Device ID | K941457 |
| 510k Number | K941457 |
| Device Name: | UTERINE INJECTOR WITH SPRING |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
| Contact | Trish Willging |
| Correspondent | Trish Willging 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 | 1994-03-25 |
| Decision Date | 1995-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937013317 | K941457 | 000 |