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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Garment, Protective, For Incontinence
510(k) Number K845010
Device Name CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH
Applicant
Chesebrough-Pond'S U.S.A. Co.
Trumbull Industrial Park
Trumbull,  CT  06611
Applicant Contact DE GRAAD
Correspondent
Chesebrough-Pond'S U.S.A. Co.
Trumbull Industrial Park
Trumbull,  CT  06611
Correspondent Contact DE GRAAD
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received12/26/1984
Decision Date 01/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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