K003712 is an FDA 510(k) clearance for the MODIFICATION TO MALE TO MALE LUER ADAPTER, a Accessories, Blood Circuit, Hemodialysis (Class II — Special Controls, product code KOC), submitted by Molded Products, Inc. (Harlan, US). The FDA issued a Cleared decision on May 16, 2001, 166 days after receiving the submission on December 1, 2000. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K003712 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 01, 2000 |
| Decision Date | May 16, 2001 |
| Days to Decision | 166 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KOC — Accessories, Blood Circuit, Hemodialysis |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |