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 |