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 |