K972731 is an FDA 510(k) clearance for the NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET, a Set, Administration, For Peritoneal Dialysis, Disposable (Class II — Special Controls, product code KDJ), submitted by Klein-Baker Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on September 29, 1997, 69 days after receiving the submission on July 22, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K972731 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 22, 1997 |
| Decision Date | September 29, 1997 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KDJ — Set, Administration, For Peritoneal Dialysis, Disposable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5630 |