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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K821130
Device Name PEDIATRIC URINE COLLECTOR
Applicant
Abco Dealers, Inc.
6637 N. Sidney Place
Milwaukee,  WI  53217 -
Applicant Contact PIYUSH M SHAH
Correspondent
Abco Dealers, Inc.
6637 N. Sidney Place
Milwaukee,  WI  53217 -
Correspondent Contact PIYUSH M SHAH
Date Received04/20/1982
Decision Date 05/10/1982
Decision Substantially Equivalent (SESE)
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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