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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Applicant
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510(K)
Number
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Decision
Date
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be-certain pregnancy test NATUREPLEX, LLC k051963 11/23/2005
beamer painlow infrared light treatment system BEAMLINE CORPORATION k052307 12/16/2005
biobands BIOBANDS DISTRIBUTORS, INC. k051397 09/16/2005
bioderm sciences wound healing spray BIODERM SCIENCES, INC. k042084 06/15/2005
bioflex prescription system and related treatment heads MEDITECH INTERNATIONAL, INC. k051875 03/13/2006
biophen normal and abnormal control plasma; biophen plasma calibrator HYPHEN BIOMED k043451 03/17/2005
bioplant KERR DENTAL MATERIALS CENTER k050984 08/11/2005
bioporta solder 1020 WIELAND DENTAL + TECHNIK GMBH & CO. KG k022462 09/18/2002
bioresorb macro pore ORALTRONICS DENTAL IMPLANT TECHNOLOGY GMBH k050260 07/15/2005
bioteque vaginal dilator BIOTEQUE AMERICA, INC. k003380 01/29/2001

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