K760793 is an FDA 510(k) clearance for the ADAPTER FOR ELLIK EVACUATOR. This device is classified as a Evacuator, Bladder, Manually Operated (Class I - General Controls, product code FFD).
Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on October 15, 1976, 8 days after receiving the submission on October 7, 1976.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4370.
| 510(k) Number | K760793 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1976 |
| Decision Date | October 15, 1976 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FFD — Evacuator, Bladder, Manually Operated |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.4370 |