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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 K950784
Device Name DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM
Applicant
Advanced Bioresearch Assoc.
1700 Rockville Pike, Suite 450
Rockville,  MD  20852
Applicant Contact STEVE REITZLER
Correspondent
Advanced Bioresearch Assoc.
1700 Rockville Pike, Suite 450
Rockville,  MD  20852
Correspondent Contact STEVE REITZLER
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received02/21/1995
Decision Date 05/03/1995
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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