K970803 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 May 29, 1997, 86 days after receiving the submission on March 4, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K970803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1997 |
| Decision Date | May 29, 1997 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | MEG - Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |