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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 K033927
Device Name ARTHOSCOPY PUMP A115
Applicant
W.O.M. World of Medicine AG
368 N. Asaph St.
Alexandria,  VA  22314
Applicant Contact SUSANNE RAAB
Correspondent
W.O.M. World of Medicine AG
368 N. Asaph St.
Alexandria,  VA  22314
Correspondent Contact SUSANNE RAAB
Regulation Number888.1100
Classification Product Code
HRX  
Date Received12/18/2003
Decision Date 01/15/2004
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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