The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Vaginal Specula: Cusco, Guttman, Infant.
Device ID | K892693 |
510k Number | K892693 |
Device Name: | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT |
Classification | Instrument, Manual, General Obstetric-gynecologic |
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 | KOH |
CFR Regulation Number | 884.4520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-13 |
Decision Date | 1989-05-11 |