The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Aim Light Source And Safelight Cable.
Device ID | K173866 |
510k Number | K173866 |
Device Name: | Stryker AIM Light Source And SafeLight Cable |
Classification | Confocal Optical Imaging |
Applicant | Stryker 5900 Optical Court San Jose, CA 95138 |
Contact | Jay Nayar |
Correspondent | Jay Nayar Stryker 5900 Optical Court San Jose, CA 95138 |
Product Code | OWN |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2017-12-20 |
Decision Date | 2018-01-18 |
Summary: | summary |