K946219 is an FDA 510(k) clearance for the POP-N-LOK SYRINGE. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Retractable Technologies, Inc. (Lewisville, US). The FDA issued a Cleared decision on December 28, 1995, 372 days after receiving the submission on December 21, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K946219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1994 |
| Decision Date | December 28, 1995 |
| Days to Decision | 372 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEG - Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |