K885208 is an FDA 510(k) clearance for the RECEPTAL SAF-GARD(TM) SYSTEM. This device is classified as a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II - Special Controls, product code GCX).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 17, 1989, 88 days after receiving the submission on December 19, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K885208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | December 19, 1988 |
| Decision Date | March 17, 1989 |
| Days to Decision | 88 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 |