K881395 is an FDA 510(k) clearance for the GAUZE AND LAP SPONGES -STERILE & NON-STERILE. This device is classified as a Gauze/sponge, Internal.
Submitted by A Plus International, Inc. (La Puente, US). The FDA issued a Cleared decision on April 28, 1988, 24 days after receiving the submission on April 4, 1988.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K881395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1988 |
| Decision Date | April 28, 1988 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | EFQ - Gauze/sponge, Internal |
| Device Class | - |