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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name arthroscope
510(k) Number K041454
Device Name KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
Applicant
KYPHON, INC.
1221 CROSSMAN AVE.
SUNNYVALE,  CA  94089
Applicant Contact CINDY DOMESCUS
Correspondent
KYPHON, INC.
1221 CROSSMAN AVE.
SUNNYVALE,  CA  94089
Correspondent Contact CINDY DOMESCUS
Regulation Number888.1100
Classification Product Code
HRX  
Date Received06/01/2004
Decision Date 07/09/2004
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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