FDA 510(k) Application Details - K010303

Device Classification Name Tester, Stiffness, Cartilage, Arthroscopic

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510(K) Number K010303
Device Name Tester, Stiffness, Cartilage, Arthroscopic
Applicant ARTSCAN MEDICAL INNOVATIONS
4804 OIN OAK RD.
AKRON, OH 44333 US
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Contact ROBERT ANTHONY
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Regulation Number 888.1100

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Classification Product Code NGR
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Date Received 12/05/2000
Decision Date 09/11/2001
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

FDA Source Information for K010303


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