The following data is part of a premarket notification filed by T. Koros Surgical Instruments Corp. with the FDA for Non-absorbing Sternatomy Monofilament Suture.
| Device ID | K002755 |
| 510k Number | K002755 |
| Device Name: | NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE |
| Classification | Wire, Surgical |
| Applicant | T. KOROS SURGICAL INSTRUMENTS CORP. 610 FLINN AVE. Moorpark, CA 93021 |
| Contact | Tibor Koros |
| Correspondent | Tibor Koros T. KOROS SURGICAL INSTRUMENTS CORP. 610 FLINN AVE. Moorpark, CA 93021 |
| Product Code | LRN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-05 |
| Decision Date | 2000-12-04 |