K903947 is an FDA 510(k) clearance for the QUALTEX NEEDLE COUNTERS. This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on October 30, 1990, 64 days after receiving the submission on August 27, 1990.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K903947 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1990 |
| Decision Date | October 30, 1990 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | MMK — Container, Sharps |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |