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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K110954
Device Name ARJORAD STERILE WRAP
Applicant
Arjo Wiggins Medical, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Applicant Contact JON WARD
Correspondent
Arjo Wiggins Medical, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Correspondent Contact JON WARD
Regulation Number880.6850
Classification Product Code
FRG  
Date Received04/05/2011
Decision Date 08/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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