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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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streerable ptca guidewire LAKE REGION MFG., INC. k011968 07/25/2001
clearfil porcelain bond activator KURARAY MEDICAL INC. k012730 09/13/2001
caries detector KURARAY MEDICAL INC. k012733 09/14/2001
clearfil new bond KURARAY MEDICAL INC. k012734 09/14/2001
clearfil dc cement KURARAY MEDICAL INC. k012735 09/14/2001
chroma zone color stain KURARAY MEDICAL INC. k012737 09/14/2001
clearfil ap-x KURARAY MEDICAL INC. k012740 09/14/2001
teethmate f-1 KURARAY MEDICAL INC. k012742 09/14/2001
royal imperial powdered latex examination gloves with protein content labeling claim (200 micrograms or less) KOON SENG SDN.BHD k013537 12/07/2001
xub external ultrasound KMI KOLSTER METHODS, INC. k010702 08/09/2001

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