K993544 is an FDA 510(k) clearance for the SPACE-OR RETRACTOR. This device is classified as a Retractor, Self-retaining (Class I - General Controls, product code FFO).
Submitted by Advanced Surgical Concepts (Asc) (North Attleboro, US). The FDA issued a Cleared decision on December 22, 1999, 64 days after receiving the submission on October 19, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4730.
| 510(k) Number | K993544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1999 |
| Decision Date | December 22, 1999 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFO — Retractor, Self-retaining |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.4730 |