The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Zsi Laparoscopes-general & Plastic Surgery.
Device ID | K926181 |
510k Number | K926181 |
Device Name: | ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY |
Classification | Laparoscope, General & Plastic Surgery |
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 | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-08 |
Decision Date | 1993-12-17 |