The following data is part of a premarket notification filed by Koros Usa, Inc. with the FDA for Self Retaining Soft Tissue Retractor.
| Device ID | K101609 |
| 510k Number | K101609 |
| Device Name: | SELF RETAINING SOFT TISSUE RETRACTOR |
| Classification | Orthopedic Manual Surgical Instrument |
| Applicant | KOROS USA, INC. 610 FLINN AVE. Moorpark, CA 93021 |
| Contact | Tibor Koros |
| Correspondent | Tibor Koros KOROS USA, INC. 610 FLINN AVE. Moorpark, CA 93021 |
| Product Code | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-08 |
| Decision Date | 2010-12-09 |