FDA 510(k) Application Details - K151932

Device Classification Name Arthroscope

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510(K) Number K151932
Device Name Arthroscope
Applicant STRYKER CORPORATION
5900 OPTICAL CT
SAN JOSE, CA 95138 US
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Contact SOMI EKWEALOR
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 07/14/2015
Decision Date 03/31/2016
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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