The following data is part of a premarket notification filed by Starcap Medical Llc ( Dba Prism Medical & Design) with the FDA for Protexsure Safety Capsule System.
| Device ID | K152597 |
| 510k Number | K152597 |
| Device Name: | ProteXsure Safety Capsule System |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | StarCap Medical LLC ( DBA Prism Medical & Design) 9604 Exbury Court Parkland, FL 33076 |
| Contact | Les Capella |
| Correspondent | Matt Hedlund StarCap Medical, LLC 3924 NE 157TH Pl. Lake Forest Park, WA 98155 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-11 |
| Decision Date | 2016-06-08 |