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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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rdi cardiac insulation pad R D Intl. k960312 04/19/1996
raichem amylase reagent Reagents Applications, Inc. k861269 05/29/1986
r120 modular total hip system Osteoimplant Technology, Inc. k011774 09/05/2001
quantimetrix total creatine kinase control Quantimetrix Medical Industries k874302 02/02/1988
quadtrax Body Bike, Inc. k935201 05/06/1994
puritan-bennett nasal cpap mask Puritan-Bennett k942246 07/06/1994
pump tubing Terumo Cardiovascular Systems Corp. k013578 01/22/2002
pulsed light therapy system, model prima New Star Lasers, Inc. k041323 11/17/2004
pulse oximeter Beijing Choice Electronic Technology Co., Ltd. k220101 03/08/2023
protologic model ser-1 Protologic, Inc. k894936 01/22/1990

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