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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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portable breast compression device PEM TECHNOLOGIES k003775 01/12/2001
foramatron v, model d680 PARKELL, INC. k002195 08/30/2000
positube PARAPRODUCTS, INC. k000045 03/15/2000
powder-free polymer-coated latex examination gloves PAMITEX INDUSTRIES SDN BHD k001672 06/23/2000
powder-free latex examination gloves-blue color PAMITEX INDUSTRIES SDN BHD k001674 06/30/2000
unipolar needles PAJUNK GMBH k000722 03/31/2000
temporary pacemaker extension cable, models 5235, 5235a, 5235v, temporary pacemaker surgical extension cable, models 528 PACE MEDICAL k001180 06/27/2000
pacemaker extension cable models 4265,4265a, 4265v, 5265, 5265a, 5265v PACE MEDICAL k002204 10/18/2000
tcoyf fertility software version 1.0 OVUSOFT, LLC. k002726 04/06/2001
evantgarde/endeavor powered wheelchair OTTO BOCK ORTHOPEDIC INDUSTRY, INC. k000739 10/24/2000

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