K760217 is an FDA 510(k) clearance for the SUCTION INSTRUMENT, MACBICK DIS. FRAZ.. This device is classified as a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II - Special Controls, product code GCX).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 23, 1976, 42 days after receiving the submission on July 12, 1976.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K760217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 1976 |
| Decision Date | August 23, 1976 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | GCX — Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |