The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Surgical Instruments And Accessories.
| Device ID | K942956 |
| 510k Number | K942956 |
| Device Name: | SURGICAL INSTRUMENTS AND ACCESSORIES |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Tammy Lounds |
| Correspondent | Tammy Lounds STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-23 |
| Decision Date | 1994-09-23 |