K780848 is an FDA 510(k) clearance for the PORTABLE CLOSED WOUND SUCTION EVACUATOR. This device is classified as a Apparatus, Suction, Single Patient Use, Portable, Nonpowered (Class I - General Controls, product code GCY).
Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 23, 1978, 92 days after receiving the submission on May 23, 1978.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4680.
| 510(k) Number | K780848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 1978 |
| Decision Date | August 23, 1978 |
| Days to Decision | 92 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 |