FDA 510(k) Application Details - K041454

Device Classification Name Arthroscope

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510(K) Number K041454
Device Name Arthroscope
Applicant KYPHON, INC.
1221 CROSSMAN AVE.
SUNNYVALE, CA 94089 US
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Contact CINDY DOMESCUS
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 06/01/2004
Decision Date 07/09/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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