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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K070874
Device Name ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR
Applicant
Arthro Kinetics, Inc.
8 Faneuil Hall, 3rd Floor
Boston,  MA  02109
Applicant Contact JAMES HOBBS
Correspondent
Arthro Kinetics, Inc.
8 Faneuil Hall, 3rd Floor
Boston,  MA  02109
Correspondent Contact JAMES HOBBS
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/29/2007
Decision Date 11/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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