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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 K990443
Device Name ARTHRO-SURGIMAT-2000 ECU
Applicant
W.O.M. World of Medicine GmbH
194 Branch St.
Mansfield,  MA  02048
Applicant Contact MICHAEL MCGRAIL
Correspondent
W.O.M. World of Medicine GmbH
194 Branch St.
Mansfield,  MA  02048
Correspondent Contact MICHAEL MCGRAIL
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/11/1999
Decision Date 02/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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