K953681 is an FDA 510(k) clearance for the HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET, a Separator, Automated, Blood Cell And Plasma, Therapeutic, submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on June 4, 1996, 302 days after receiving the submission on August 7, 1995. This device falls under the Gastroenterology & Urology review panel.
| 510(k) Number | K953681 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 07, 1995 |
| Decision Date | June 04, 1996 |
| Days to Decision | 302 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LKN — Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Device Class | — |