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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 K132476
Device Name SHARPS CONTAINER
Applicant
Grp & Associates
816 Congress
Suite 1400
Austin,  TX  78701
Applicant Contact ROBERT SEIPLE
Correspondent
Grp & Associates
816 Congress
Suite 1400
Austin,  TX  78701
Correspondent Contact ROBERT SEIPLE
Regulation Number880.5570
Classification Product Code
MMK  
Date Received08/08/2013
Decision Date 05/02/2014
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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