K880704 is an FDA 510(k) clearance for the CERULLO SUCTION REGULATOR. This device is classified as a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II - Special Controls, product code GCX).
Submitted by Aesculap Instruments Corp. (Burlingame, US). The FDA issued a Cleared decision on March 29, 1988, 36 days after receiving the submission on February 22, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K880704 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 1988 |
| Decision Date | March 29, 1988 |
| Days to Decision | 36 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 |