The following data is part of a premarket notification filed by Hall Surgical, Division Of Zimmer, Inc. with the FDA for Hall Microchoice Electric Powered System.
| Device ID | K942660 |
| 510k Number | K942660 |
| Device Name: | HALL MICROCHOICE ELECTRIC POWERED SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | HALL SURGICAL, DIVISION OF ZIMMER, INC. 1170 MARK AVE. Carpinteria, CA 93013 -2918 |
| Contact | Terry Fenandez |
| Correspondent | Terry Fenandez HALL SURGICAL, DIVISION OF ZIMMER, INC. 1170 MARK AVE. Carpinteria, CA 93013 -2918 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-06 |
| Decision Date | 1994-09-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854023119 | K942660 | 000 |
| 20845854023164 | K942660 | 000 |
| 20845854023157 | K942660 | 000 |
| 10845854002575 | K942660 | 000 |
| 10845854023334 | K942660 | 000 |
| 10845854023327 | K942660 | 000 |