K851309 is an FDA 510(k) clearance for the ABCO PLASTIC UTENSILS. This device is classified as a Bath, Sitz, Nonpowered (Class I - General Controls, product code KTC).
Submitted by Abco Dealers, Inc. (Milwaukee, US). The FDA issued a Cleared decision on July 1, 1985, 90 days after receiving the submission on April 2, 1985.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5125.
| 510(k) Number | K851309 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1985 |
| Decision Date | July 01, 1985 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | KTC — Bath, Sitz, Nonpowered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5125 |