FDA 510(k) Application Details - K162475

Device Classification Name Arthroscope

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510(K) Number K162475
Device Name Arthroscope
Applicant Trice Medical
1000 Continental Dr. Suite 240
King of Prussia, PA 19406 US
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Contact Tiffini Diage
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 09/06/2016
Decision Date 09/16/2016
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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