The following data is part of a premarket notification filed by Micro Surgical Instruments Corp. with the FDA for Electric Wire Driver, Model 2640e.
Device ID | K930205 |
510k Number | K930205 |
Device Name: | ELECTRIC WIRE DRIVER, MODEL 2640E |
Classification | Staple Driver |
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 | HXJ |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-15 |
Decision Date | 1993-08-02 |