K811632 is an FDA 510(k) clearance for the UNSTERILIZED LAPAROTOMY SPONGES (CHINA). This device is classified as a Gauze/sponge, Internal, X-ray Detectable (Class I - General Controls, product code GDY).
Submitted by Robert I. Chien & Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1981, 94 days after receiving the submission on June 9, 1981.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4450.
| 510(k) Number | K811632 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1981 |
| Decision Date | September 11, 1981 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDY — Gauze/sponge, Internal, X-ray Detectable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4450 |