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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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510(K)
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Decision
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microscan microstrep plus panel new antimicrobial - cefaclor DADE MICROSCAN, INC. k020691 04/30/2002
calibrating material, cal-pak, buffers MISSION DIAGNOSTICS k020894 04/29/2002
ocu-flex-53 custom prosthetic (ocufilcon b) soft contact lens OCU-EASE OPTICAL PRODUCTS, INC. k020690 04/26/2002
siis#1 tissue suspension system TAG MEDICAL PRODUCTS k020705 04/26/2002
serralsilk SERRAL, S.A. DE C.V. k020901 04/26/2002
qab2a igm elisa kit CHESHIRE DIAGNOSTICS LTD. k020694 04/19/2002
qab2a igg elisa kit CHESHIRE DIAGNOSTICS LTD. k020695 04/19/2002
spyglass 4 fr angiographicy catheter ST. JUDE MEDICAL k020890 04/17/2002
spiral radius 90-d rodding system UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC k020134 04/15/2002
nbx - non-bridging external fixator BIOMET ORTHOPEDICS, INC. k020905 04/15/2002

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