FDA 510(k) Application Details - K141119

Device Classification Name Arthroscope

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510(K) Number K141119
Device Name Arthroscope
Applicant TRICE MEDICAL, INC.
1000 CONTINENTAL DRIVE, 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 04/30/2014
Decision Date 07/29/2014
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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