K910821 is an FDA 510(k) clearance for the TRANSDUCER PROTECTOR. This device is classified as a Protector, Transducer, Dialysis (Class II - Special Controls, product code FIB).
Submitted by Gelman Sciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on August 12, 1991, 167 days after receiving the submission on February 26, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K910821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 1991 |
| Decision Date | August 12, 1991 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FIB — Protector, Transducer, Dialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |