The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Scissors: Thorek, Jorgensen, Finochietto.
Device ID | K891203 |
510k Number | K891203 |
Device Name: | SCISSORS: THOREK, JORGENSEN, FINOCHIETTO |
Classification | Scissors, General, Surgical |
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 | LRW |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-06 |
Decision Date | 1989-04-06 |