K963364 is an FDA 510(k) clearance for the GLASS VAN GLASS SYRINGES. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Myco Medical Supplies, Inc. (Raleigh, US). The FDA issued a Cleared decision on May 1, 1998, 613 days after receiving the submission on August 26, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K963364 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 1996 |
| Decision Date | May 01, 1998 |
| Days to Decision | 613 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |