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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 K132792
Device Name ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER
Applicant
Daniels Sharpsmart, Inc.
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Applicant Contact ALLISON KOMIYAMA
Correspondent
Daniels Sharpsmart, Inc.
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact ALLISON KOMIYAMA
Regulation Number880.5570
Classification Product Code
MMK  
Date Received09/06/2013
Decision Date 01/31/2014
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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