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FDA 510(k) Application Details - K103248
Device Classification Name
Equipment, Traction, Powered
More FDA Info for this Device
510(K) Number
K103248
Device Name
Equipment, Traction, Powered
Applicant
INTEGRA LIFE SCIENCES
5795 SOUTH SANDHILL ROAD
SUITE F,
LAS VEGAS, NV 89120 US
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Contact
JAMES J GIBSON
Other 510(k) Applications for this Contact
Regulation Number
890.5900
More FDA Info for this Regulation Number
Classification Product Code
ITH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/03/2010
Decision Date
04/05/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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