K883299 is an FDA 510(k) clearance for the SUTURE RETENTION DEVICE. This device is classified as a Retention Device, Suture (Class I - General Controls, product code KGS).
Submitted by Edwards Orthopaedics Div., Baxter Healthcare Corp. (Santa Ana, US). The FDA issued a Cleared decision on August 23, 1988, 19 days after receiving the submission on August 4, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4930.
| 510(k) Number | K883299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1988 |
| Decision Date | August 23, 1988 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KGS — Retention Device, Suture |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4930 |