K894801 is an FDA 510(k) clearance for the 30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on September 19, 1989, 53 days after receiving the submission on July 28, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K894801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 1989 |
| Decision Date | September 19, 1989 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |