The following data is part of a premarket notification filed by Koros Usa, Inc. with the FDA for Flex Arm Retractor System.
| Device ID | K071338 |
| 510k Number | K071338 |
| Device Name: | FLEX ARM RETRACTOR SYSTEM |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | KOROS USA, INC. 610 FLINN AVE. Moorpark, CA 93021 |
| Contact | Gabriel Koros |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-05-14 |
| Decision Date | 2007-05-29 |