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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
Date
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y2000 manual resuscitator, model rugu01/rug02 and rugh01/rugh02 CHEEN HOUNG ENT. CO. LTD. k003927 06/26/2001
y-tzp powder and procera allzirkon PROCERA SANDVIK, INC. k010630 04/17/2001
xia spine system sacral block assembly HOWMEDICA OSTEONICS CORP. k001653 08/18/2000
x-sept transseptal sheath and transition catheter, model mv-03-09-90, mv-03-10-90, mv-03-11-90, mv-03-09-120, mv-03-10-1 APPRIVA MEDICAL, INC. k002054 02/16/2001
willi geller creation & av porcelain JENSEN INDUSTRIES, INC. k002041 08/16/2000
water purification system for hemodialysis TOTAL WATER TREATMENT SYSTEMS, INC. k002045 02/16/2001
warmtouch patient warming system, model 5300 NELLCOR PURITAN BENNETT, INC. k020604 04/23/2002
wallgraft tracheobronchial endoprosthesis and unistep delivery system BOSTON SCIENTIFIC SCIMED, INC. k000001 06/05/2000
voluson 730 diagnostic ultrasound system MEDISON AMERICA, INC. k003525 11/22/2000
vivid 7 with sonopac, model fb0008xx GE MEDICAL SYSTEMS, INC. k003931 01/18/2001

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