FDA 510(k) Application Details - K133018

Device Classification Name Arthroscope

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510(K) Number K133018
Device Name Arthroscope
Applicant ORTHOPEDIC SCIENCES, INC
12264 EI CAMINO REAL SUITE 400
SAN DIEGO, CA 92130 US
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Contact KEVIN A THOMAS
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 09/25/2013
Decision Date 02/26/2014
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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