K910171 is an FDA 510(k) clearance for the MAXI-FLOW SUCTION SET W/Y CONNECTOR. This device is classified as a Tubing, Noninvasive (Class II - Special Controls, product code GAZ).
Submitted by Adler Instrument Co. (Norcross, US). The FDA issued a Cleared decision on February 1, 1991, 17 days after receiving the submission on January 15, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K910171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 1991 |
| Decision Date | February 01, 1991 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | GAZ — Tubing, Noninvasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |