FDA 510(k) Application Details - K130430

Device Classification Name Arthroscope

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510(K) Number K130430
Device Name Arthroscope
Applicant STRYKER CORPORATION
4100 E. MILHAM AVE
KALAMAZOO, MI 49001 US
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Contact CHRISTINA MCKEE
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 02/20/2013
Decision Date 05/23/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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