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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)
Number
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Decision
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ids5 image display system SECTRA AB k001140 05/03/2000
sea-long medical treatment hood SEA-LONG MEDICAL SYSTEMS, INC. k010659 05/16/2001
gliadin iga antibody eia detection system SCIMEDX CORP. k002169 10/19/2000
gliadin igg antibody eia detection system SCIMEDX CORP. k002189 10/19/2000
snore sat recorder, model ss41 SAGATECH ELECTRONICS, INC. k002159 06/28/2002
thermo tek ir forehead thermometer, model 718f S.A.A.T., LTD. k002712 02/08/2001
classic cem S & C POLYMER GMBH k011064 05/17/2001
tampons ROSTAM LTD. k001641 08/03/2000
wristwatch blood pressure monitor, model a43 ROSSMAX INTERNATIONL LTD. k010190 02/08/2001
aspiject self-aspirating dental injection syringe RONVIG INSTRUMENTS, LTD. k002168 10/13/2000

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