The following data is part of a premarket notification filed by Tava Surgical Instruments with the FDA for Micro Surgical Instrument System.
Device ID | K884492 |
510k Number | K884492 |
Device Name: | MICRO SURGICAL INSTRUMENT SYSTEM |
Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
Applicant | TAVA SURGICAL INSTRUMENTS 7756 BURNETT AVE. Van Nuys, CA 91405 |
Contact | Terry M Mattchen |
Correspondent | Terry M Mattchen TAVA SURGICAL INSTRUMENTS 7756 BURNETT AVE. Van Nuys, CA 91405 |
Product Code | HSZ |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-26 |
Decision Date | 1988-11-16 |