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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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reference check, catalog number-rcn-10 PRECISION BIOLOGIC k013708 12/10/2001
reach femoral component BIOMET, INC. k000760 05/23/2000
re-usable sterilization pouch / bag QUALITY PRODUCTS OF MONTANA k013715 04/01/2002
rapid thermal exchange system AVACORE TECHNOLOGIES, INC. k023934 01/23/2003
raichem creatinine urine standard HEMAGEN DIAGNOSTICS, INC. k011126 05/02/2001
quickvue dipstick strep a QUIDEL CORP. k011097 05/08/2001
quickclot ON SITE GAS SYSTEMS, INC. k013390 05/23/2002
qflow 500 perfusion monitoring system HEMEDEX INCORPORATED k013376 05/08/2002
pulpdent triple-cure reinforced glass ionomer orthodontic cement PULPDENT CORP. k014138 03/14/2002
pulpdent no-mix orthodontic bracket adhesive PULPDENT CORP. k014133 03/14/2002

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