URETERAL CATHETER AND ACCESSORIES

Connector, Ureteral Catheter

UROLOGICAL ASSOCIATES OF CENTRAL JERSEY P.A.

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.

Pre-market Notification Details

Device IDK934419
510k NumberK934419
Device Name:URETERAL CATHETER AND ACCESSORIES
ClassificationConnector, Ureteral Catheter
Applicant UROLOGICAL ASSOCIATES OF CENTRAL JERSEY P.A. 904 OAK TREE RD. SUITE J South Plainfield,  NJ  07080
ContactAnthony Solazzo
CorrespondentAnthony Solazzo
UROLOGICAL ASSOCIATES OF CENTRAL JERSEY P.A. 904 OAK TREE RD. SUITE J South Plainfield,  NJ  07080
Product CodeEYK  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-13
Decision Date1994-05-25

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