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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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exel secure touch safety a.v. fistula needle set EXELINT INTERNATIONAL CO. k003627 02/08/2001
magnetom rhapsody system SIEMENS MEDICAL SOLUTIONS USA, INC. k003628 01/23/2001
mtp resesurfacing joint-small/9301-01; medium/9301-02; large/9301-03 TERRAY CORP. k003629 02/22/2001
danmar products michigan cranial helmet DANMAR PRODUCTS, INC. k003630 05/29/2001
smartwave if 2000 NEWWAVE MEDICAL LLC. k003631 08/10/2001
dw 273 #1 IVOCLAR NORTH AMERICA, INC. k003632 12/20/2000
dw 277 #4 IVOCLAR NORTH AMERICA, INC. k003633 12/20/2000
dw 272 #1 IVOCLAR NORTH AMERICA, INC. k003634 12/21/2000
dw 276 #3 IVOCLAR NORTH AMERICA, INC. k003635 12/22/2000
portalvision VARIAN MEDICAL SYSTEMS, INC. k003636 02/02/2001

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