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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Stiffness, Cartilage, Arthroscopic
510(k) Number K010303
Device Name ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE
Applicant
Artscan Medical Innovations
4804 Oin Oak Rd.
Akron,  OH  44333
Applicant Contact ROBERT ANTHONY
Correspondent
Artscan Medical Innovations
4804 Oin Oak Rd.
Akron,  OH  44333
Correspondent Contact ROBERT ANTHONY
Regulation Number888.1100
Classification Product Code
NGR  
Date Received12/05/2000
Decision Date 09/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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