The following data is part of a premarket notification filed by Genzyme Biosurgery with the FDA for Radlite Tissue Retractor System.
| Device ID | K022989 |
| 510k Number | K022989 |
| Device Name: | RADLITE TISSUE RETRACTOR SYSTEM |
| Classification | Light, Surgical, Endoscopic |
| Applicant | GENZYME BIOSURGERY 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Contact | Karen K Sylvia |
| Correspondent | Karen K Sylvia GENZYME BIOSURGERY 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Product Code | FSW |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-09 |
| Decision Date | 2002-11-25 |
| Summary: | summary |