K863201 is an FDA 510(k) clearance for the NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC. This device is classified as a Apparatus, Suction, Single Patient Use, Portable, Nonpowered (Class I - General Controls, product code GCY).
Submitted by Allergan, Inc. (Santa Ana, US). The FDA issued a Cleared decision on August 29, 1986, 10 days after receiving the submission on August 19, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4680.
| 510(k) Number | K863201 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1986 |
| Decision Date | August 29, 1986 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | GCY - Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4680 |