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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Decontamination Kit
510(k) Number K023969
Device Name REACTIVE SKIN DECONTAMINATION LOTION
Applicant
Dept. of the Army
Chemical-Biological Mgt.Office
64 Thomas Jefferson Dr.
Fort Detrick,  MD  21702
Applicant Contact RONALD E CLAWSON
Correspondent
Dept. of the Army
Chemical-Biological Mgt.Office
64 Thomas Jefferson Dr.
Fort Detrick,  MD  21702
Correspondent Contact RONALD E CLAWSON
Regulation Number878.4014
Classification Product Code
MAC  
Date Received11/29/2002
Decision Date 03/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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