The following data is part of a premarket notification filed by Porges S.a. with the FDA for Porges Silicone Double Loop Ureteral Stent, Model # Aj4x / Bj1x / Bj2x.
| Device ID | K013921 |
| 510k Number | K013921 |
| Device Name: | PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X |
| Classification | Stent, Ureteral |
| Applicant | PORGES S.A. CENTRE D'AFFAIRES LA BOURSIDIERE Le Plessis Robinson Cedex, FR 92357 |
| Contact | Bernard Ismael |
| Correspondent | Bernard Ismael PORGES S.A. CENTRE D'AFFAIRES LA BOURSIDIERE Le Plessis Robinson Cedex, FR 92357 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-27 |
| Decision Date | 2002-10-17 |
| Summary: | summary |