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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ureteral, Gastro-Urology
510(k) Number K083788
Device Name ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR
Applicant
ENDO OPTIKS, INC.
39 SYCAMORE AVE.
LITTLE SILVER,  NJ  07739 -1208
Applicant Contact DONALD R WATSON
Correspondent
ENDO OPTIKS, INC.
39 SYCAMORE AVE.
LITTLE SILVER,  NJ  07739 -1208
Correspondent Contact DONALD R WATSON
Regulation Number876.5130
Classification Product Code
EYB  
Date Received12/19/2008
Decision Date 03/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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