The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Knifelight, Stryker Illuminated Retractor.
| Device ID | K981717 |
| 510k Number | K981717 |
| Device Name: | STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR |
| Classification | Lamp, Surgical |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Nicole Petty |
| Correspondent | Nicole Petty STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-15 |
| Decision Date | 1998-06-30 |
| Summary: | summary |