The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Led Lightsource.
| Device ID | K082813 |
| 510k Number | K082813 |
| Device Name: | STRYKER LED LIGHTSOURCE |
| Classification | Light Source, Fiberoptic, Routine |
| Applicant | STRYKER CORP. 5900 Optical Court San Jose, CA 95138 |
| Contact | Desiree Crisolo |
| Correspondent | Desiree Crisolo STRYKER CORP. 5900 Optical Court San Jose, CA 95138 |
| Product Code | FCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-24 |
| Decision Date | 2008-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327051667 | K082813 | 000 |
| 07613327051339 | K082813 | 000 |
| 07613327051520 | K082813 | 000 |
| 07613327051537 | K082813 | 000 |
| 07613327051544 | K082813 | 000 |
| 07613327051551 | K082813 | 000 |
| 07613327051629 | K082813 | 000 |
| 07613327051636 | K082813 | 000 |
| 07613327051643 | K082813 | 000 |
| 07613327051650 | K082813 | 000 |
| 07613327051322 | K082813 | 000 |