K002755 is an FDA 510(k) clearance for the NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE. This device is classified as a Wire, Surgical (Class II - Special Controls, product code LRN).
Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on December 4, 2000, 90 days after receiving the submission on September 5, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K002755 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2000 |
| Decision Date | December 04, 2000 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | LRN — Wire, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |