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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Alcohol, Device Disinfectant
510(k) Number K896898
Device Name BOWEN ELECTRODE SKIN PREPATORY CLEANSER
Applicant
Bowen & Company, Inc.
1800 Chapman Ave.
Rockville,  MD  20852
Applicant Contact PAMELA GASPER
Correspondent
Bowen & Company, Inc.
1800 Chapman Ave.
Rockville,  MD  20852
Correspondent Contact PAMELA GASPER
Classification Product Code
LKB  
Date Received12/08/1989
Decision Date 04/04/1990
Decision Substantially Equivalent (SESE)
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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