K990355 is an FDA 510(k) clearance for the STAINLESS STEEL SOFT SUTURE WIRE. This device is classified as a Wire, Surgical (Class II - Special Controls, product code LRN).
Submitted by Bregma International Trading Company , Ltd. (Saskatoon, Saskatchewan, CA). The FDA issued a Cleared decision on July 8, 1999, 153 days after receiving the submission on February 5, 1999.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K990355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1999 |
| Decision Date | July 08, 1999 |
| Days to Decision | 153 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 |