The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Knifelight.
Device ID | K961122 |
510k Number | K961122 |
Device Name: | STRYKER KNIFELIGHT |
Classification | Lamp, Surgical |
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 | FTD |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-21 |
Decision Date | 1996-08-22 |
Summary: | summary |