K895859 is an FDA 510(k) clearance for the CONTAIN(TM). This device is classified as a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II - Special Controls, product code GCX).
Submitted by Arbor Technologies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on February 7, 1991, 492 days after receiving the submission on October 3, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K895859 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 1989 |
| Decision Date | February 07, 1991 |
| Days to Decision | 492 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 |