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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 K981251
Device Name KYPHON INFLATABLE BONE TAMP
Applicant
KYPHON, INC.
3110 CORONADO DR.
SANTA CLARA,  CA  95054
Applicant Contact KAREN TALMADGE
Correspondent
KYPHON, INC.
3110 CORONADO DR.
SANTA CLARA,  CA  95054
Correspondent Contact KAREN TALMADGE
Regulation Number888.1100
Classification Product Code
HRX  
Date Received04/06/1998
Decision Date 07/02/1998
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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