K936040 is an FDA 510(k) clearance for the HYPO(R) SAFETY CARTRIDGE SYRINGE. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Smith & Nephew, Inc. (Franklin Park, US). The FDA issued a Cleared decision on May 1, 1995, 497 days after receiving the submission on December 20, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K936040 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1993 |
| Decision Date | May 01, 1995 |
| Days to Decision | 497 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 |