The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Forceps For Laparoscopic Surgery Ob/gyn Use.
Device ID | K925960 |
510k Number | K925960 |
Device Name: | FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE |
Classification | Coagulator, Culdoscopic (and Accessories) |
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 | HFI |
CFR Regulation Number | 884.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-24 |
Decision Date | 1994-06-07 |