The following data is part of a premarket notification filed by Rhythmlink International, Llc with the FDA for Propep Delivery Device.
| Device ID | K103200 |
| 510k Number | K103200 |
| Device Name: | PROPEP DELIVERY DEVICE |
| Classification | Syringe, Piston |
| Applicant | RHYTHMLINK INTERNATIONAL, LLC 1140 FIRST STREET SOUTH Columbia, SC 29209 |
| Contact | James M Mewborne |
| Correspondent | James M Mewborne RHYTHMLINK INTERNATIONAL, LLC 1140 FIRST STREET SOUTH Columbia, SC 29209 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-01 |
| Decision Date | 2011-04-12 |
| Summary: | summary |