The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Universal Drill Attachments & Accessories.
| Device ID | K962800 |
| 510k Number | K962800 |
| Device Name: | STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Diane Davis |
| Correspondent | Diane Davis STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | HWE |
| Subsequent Product Code | GFA |
| Subsequent Product Code | GFF |
| Subsequent Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-18 |
| Decision Date | 1996-09-11 |
| Summary: | summary |