K102403 is an FDA 510(k) clearance for the SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL, a Dressing, Wound, Occlusive (Class I — General Controls, product code NAD), submitted by Sam Medical Products (Wilsonville, US). The FDA issued a Cleared decision on March 3, 2011, 191 days after receiving the submission on August 24, 2010. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4020.
| 510(k) Number | K102403 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 24, 2010 |
| Decision Date | March 03, 2011 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NAD — Dressing, Wound, Occlusive |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4020 |