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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 K091736
Device Name SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2
Applicant
Daniels Corporation Pty, Inc.
2133-126 Upton Dr.
Suite 436
Virginia Beach,  VA  23454
Applicant Contact ANDREA ARREDONDO
Correspondent
Daniels Corporation Pty, Inc.
2133-126 Upton Dr.
Suite 436
Virginia Beach,  VA  23454
Correspondent Contact ANDREA ARREDONDO
Regulation Number880.5570
Classification Product Code
MMK  
Date Received06/11/2009
Decision Date 10/30/2009
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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