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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name arthroscope
510(k) Number K133018
Device Name OSI Q SYSTEM ARTHROSCOPES
Applicant
ORTHOPEDIC SCIENCES, INC
12264 EI CAMINO REAL SUITE 400
SAN DIEGO,  CA  92130
Applicant Contact KEVIN A THOMAS
Correspondent
ORTHOPEDIC SCIENCES, INC
12264 EI CAMINO REAL SUITE 400
SAN DIEGO,  CA  92130
Correspondent Contact KEVIN A THOMAS
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/25/2013
Decision Date 02/26/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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