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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name jelly, lubricating, for transurethral surgical instrument
510(k) Number K935548
Device Name CATHEJELL S STERILE LUBRICATING JELLY
Applicant
PHARMAZEUTISCHE FABRIK MONTAVIT GMBH
CMR ASSOCIATES
372 DANBURY ROAD
WILTON,  CT  06897
Applicant Contact HENRY S PERDUE, PH.D
Correspondent
PHARMAZEUTISCHE FABRIK MONTAVIT GMBH
CMR ASSOCIATES
372 DANBURY ROAD
WILTON,  CT  06897
Correspondent Contact HENRY S PERDUE, PH.D
Regulation Number876.1500
Classification Product Code
FHX  
Date Received11/17/1993
Decision Date 03/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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