The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Hysterectomy Forceps - (several Models).
Device ID | K891036 |
510k Number | K891036 |
Device Name: | HYSTERECTOMY FORCEPS - (SEVERAL MODELS) |
Classification | Forceps, Surgical, Gynecological |
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 | HCZ |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-28 |
Decision Date | 1989-03-17 |