K880650 is an FDA 510(k) clearance for the HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS. This device is classified as a Apparatus, Suction, Single Patient Use, Portable, Nonpowered (Class I - General Controls, product code GCY).
Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on February 24, 1988, 7 days after receiving the submission on February 17, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4680.
| 510(k) Number | K880650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 1988 |
| Decision Date | February 24, 1988 |
| Days to Decision | 7 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 |