K950754 is an FDA 510(k) clearance for the MACRO SUCTION TUBE MODEL NO 10061, a Apparatus, Suction, Single Patient Use, Portable, Nonpowered (Class I — General Controls, product code GCY), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on April 25, 1995, 67 days after receiving the submission on February 17, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4680.
| 510(k) Number | K950754 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 17, 1995 |
| Decision Date | April 25, 1995 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4680 |