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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K131708
Device Name BWCSH-1 SHARPS CONTAINER
Applicant
Bradford Wright Companies, Inc.
4092 Orchard Way
Lake Oswego,  OR  97035 -1871
Applicant Contact MIKE DEMELLO
Correspondent
Bradford Wright Companies, Inc.
4092 Orchard Way
Lake Oswego,  OR  97035 -1871
Correspondent Contact MIKE DEMELLO
Regulation Number880.5570
Classification Product Code
MMK  
Date Received06/11/2013
Decision Date 03/10/2014
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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