The following data is part of a premarket notification filed by Micro Surgical Instruments Corp. with the FDA for Bone Rasps.
Device ID | K905187 |
510k Number | K905187 |
Device Name: | BONE RASPS |
Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
Applicant | MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
Contact | Moe Khosravi |
Correspondent | Moe Khosravi MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
Product Code | HSZ |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-19 |
Decision Date | 1990-12-19 |