K850756 is an FDA 510(k) clearance for the AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS. This device is classified as a Subsystem, Proportioning (Class II - Special Controls, product code FKR).
Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on March 20, 1985, 23 days after receiving the submission on February 25, 1985.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K850756 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 1985 |
| Decision Date | March 20, 1985 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FKR — Subsystem, Proportioning |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |