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FDA 510(k) Application Details - K010303
Device Classification Name
Tester, Stiffness, Cartilage, Arthroscopic
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
888.1100
More FDA Info for this Regulation Number
Classification Product Code
NGR
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More FDA Info for this Product Code
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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