FDA 510(k) Application Details - K013429

Device Classification Name Tester, Stiffness, Cartilage, Arthroscopic

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510(K) Number K013429
Device Name Tester, Stiffness, Cartilage, Arthroscopic
Applicant OSTEOBIOLOGICS, INC.
UNIVERSITY BUSINESS PARK
12500 NETWORK, SUITE 112
SAN ANTONIO, TX 78249-3308 US
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Contact MARK Q NIEDERAUER
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Regulation Number 888.1100

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Classification Product Code NGR
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Date Received 10/16/2001
Decision Date 01/11/2002
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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