Submission Details
| 510(k) Number | K910471 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 04, 1991 |
| Decision Date | March 08, 1991 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
K910471 is an FDA 510(k) clearance for the MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE, a Tubing, Noninvasive (Class II — Special Controls, product code GAZ), submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on March 8, 1991, 32 days after receiving the submission on February 4, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K910471 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 04, 1991 |
| Decision Date | March 08, 1991 |
| Days to Decision | 32 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 |