K913602 is an FDA 510(k) clearance for the IDEAS' PORT. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Ideal Medical, Inc. (Clearwater, US). The FDA issued a Cleared decision on January 2, 1992, 142 days after receiving the submission on August 13, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K913602 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | August 13, 1991 |
| Decision Date | January 02, 1992 |
| Days to Decision | 142 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 |