The following data is part of a premarket notification filed by Thomas Surgical Instruments, Inc. with the FDA for Retractor Lite.
| Device ID | K083710 |
| 510k Number | K083710 |
| Device Name: | RETRACTOR LITE |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | THOMAS SURGICAL INSTRUMENTS, INC. 10170 E. CHERRY BEND RD. Traverse City, MI 49684 |
| Contact | Stephanie A Zalucha |
| Correspondent | Stephanie A Zalucha THOMAS SURGICAL INSTRUMENTS, INC. 10170 E. CHERRY BEND RD. Traverse City, MI 49684 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-15 |
| Decision Date | 2009-02-23 |
| Summary: | summary |