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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 K041824
Device Name X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
Applicant
FUTURE MEDICAL SYSTEMS, SA
265 ROUTE DE LA BARONNE
ST. JEANNET,  FR 06640
Applicant Contact PATRICK JANIN
Correspondent
FUTURE MEDICAL SYSTEMS, SA
265 ROUTE DE LA BARONNE
ST. JEANNET,  FR 06640
Correspondent Contact PATRICK JANIN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/06/2004
Decision Date 01/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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