The following data is part of a premarket notification filed by Micro Surgical Instruments Corp. with the FDA for Series 5000 Battery Powered Instrument System.
| Device ID | K931395 |
| 510k Number | K931395 |
| Device Name: | SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Contact | Shirajul Karim |
| Correspondent | Shirajul Karim MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-19 |
| Decision Date | 1994-01-28 |