K973301 is an FDA 510(k) clearance for the ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Retractable Technologies, Inc. (Little Elm, US). The FDA issued a Cleared decision on November 7, 1997, 66 days after receiving the submission on September 2, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K973301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 1997 |
| Decision Date | November 07, 1997 |
| Days to Decision | 66 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 |