The following data is part of a premarket notification filed by Urological Associates Of Central Jersey P.a. with the FDA for Ureteral Catheter And Accessories.
| Device ID | K934419 | 
| 510k Number | K934419 | 
| Device Name: | URETERAL CATHETER AND ACCESSORIES | 
| Classification | Connector, Ureteral Catheter | 
| Applicant | UROLOGICAL ASSOCIATES OF CENTRAL JERSEY P.A. 904 OAK TREE RD. SUITE J South Plainfield, NJ 07080 | 
| Contact | Anthony Solazzo | 
| Correspondent | Anthony Solazzo UROLOGICAL ASSOCIATES OF CENTRAL JERSEY P.A. 904 OAK TREE RD. SUITE J South Plainfield, NJ 07080 | 
| Product Code | EYK | 
| CFR Regulation Number | 876.5130 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1993-09-13 | 
| Decision Date | 1994-05-25 |