FDA 510(k) Application Details - K172116

Device Classification Name Arthroscope

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510(K) Number K172116
Device Name Arthroscope
Applicant Stryker Corporation
4100 E. Milham Avenue
Kalamazoo, MI 49001 US
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Contact Kristi Ashton
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 07/13/2017
Decision Date 01/25/2018
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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