The following data is part of a premarket notification filed by East West Instruments, Inc. with the FDA for East West Instruments.
| Device ID | K941193 |
| 510k Number | K941193 |
| Device Name: | EAST WEST INSTRUMENTS |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | EAST WEST INSTRUMENTS, INC. 1062 N. HIGHLAND AVE. Aurora, IL 60506 |
| Contact | Tahir Choudhry |
| Correspondent | Tahir Choudhry EAST WEST INSTRUMENTS, INC. 1062 N. HIGHLAND AVE. Aurora, IL 60506 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-11 |
| Decision Date | 1994-11-09 |