K103200 is an FDA 510(k) clearance for the PROPEP DELIVERY DEVICE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on April 12, 2011, 162 days after receiving the submission on November 1, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K103200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2010 |
| Decision Date | April 12, 2011 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |