The following data is part of a premarket notification filed by Porges S.a. with the FDA for Porges Silicone Prostatectomy Catheter, Straight Cylindrical Tip, Delinotte Tip, Dufour Tip, Over The Guide Tip, Model.
| Device ID | K013172 |
| 510k Number | K013172 |
| Device Name: | PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL |
| Classification | Catheter, Retention Type, Balloon |
| 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 | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-24 |
| Decision Date | 2001-12-20 |
| Summary: | summary |