The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Uterine Cannula - Kahn, Jarco, Corson, Ratchet.
Device ID | K891028 |
510k Number | K891028 |
Device Name: | UTERINE CANNULA - KAHN, JARCO, CORSON, RATCHET |
Classification | Insufflator, Hysteroscopic |
Applicant | ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
Contact | Anna Straight |
Correspondent | Anna Straight ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
Product Code | HIG |
CFR Regulation Number | 884.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-28 |
Decision Date | 1989-03-17 |