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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement, bone, vertebroplasty
510(k) Number K033801
Device Name KYPHX HV-R, MODEL C01A
Applicant
KYPHON, INC.
1350 BORDEAUX DR.
SUNNYVALE,  CA  94089
Applicant Contact CINDY DOMECUS
Correspondent
KYPHON, INC.
1350 BORDEAUX DR.
SUNNYVALE,  CA  94089
Correspondent Contact CINDY DOMECUS
Regulation Number888.3027
Classification Product Code
NDN  
Date Received12/08/2003
Decision Date 04/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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