The following data is part of a premarket notification filed by Micro Surgical Instruments Corp. with the FDA for 2710-000 Oscillating Saw, General Assembly.
Device ID | K905383 |
510k Number | K905383 |
Device Name: | 2710-000 OSCILLATING SAW, GENERAL ASSEMBLY |
Classification | Motor, Surgical Instrument, Ac-powered |
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 | GEY |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-29 |
Decision Date | 1991-06-18 |