The following data is part of a premarket notification filed by Porges S.a. with the FDA for Porges Ureteral Catheters, Models Acn6xx, Acn5xx, Ac5b, Ac5c07, Acp5xx, Acp2xx, Acp3xx, Acp4xx, Acp6xx.
| Device ID | K021856 |
| 510k Number | K021856 |
| Device Name: | PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX |
| Classification | Catheter, Ureteral, Gastro-urology |
| 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 | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-06 |
| Decision Date | 2002-10-17 |
| Summary: | summary |