The following data is part of a premarket notification filed by Stryker with the FDA for L10 Led Light Source With Aim, L11 Led Light Source With Aim, Aim Safelight Cable.
| Device ID | K192292 |
| 510k Number | K192292 |
| Device Name: | L10 LED Light Source With AIM, L11 LED Light Source With AIM, AIM SafeLight Cable |
| Classification | Confocal Optical Imaging |
| Applicant | Stryker 5900 Optical Court San Jose, CA 95138 |
| Contact | April Malmborg |
| Correspondent | April Malmborg Stryker 5900 Optical Court San Jose, CA 95138 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-23 |
| Decision Date | 2019-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327462777 | K192292 | 000 |
| 07613327462760 | K192292 | 000 |