K990584 is an FDA 510(k) clearance for the GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE. This device is classified as a Gauze/sponge, Internal.
Submitted by Broadline Medical Industries (Inverness, US). The FDA issued a Cleared decision on April 23, 1999, 59 days after receiving the submission on February 23, 1999.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K990584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1999 |
| Decision Date | April 23, 1999 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | EFQ — Gauze/sponge, Internal |
| Device Class | — |