K082396 is an FDA 510(k) clearance for the DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on January 2, 2009, 136 days after receiving the submission on August 19, 2008.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K082396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2008 |
| Decision Date | January 02, 2009 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDW — Staple, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4750 |