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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 K093409
Device Name POWERPUMP ARTHROSCOPY SYSTEM
Applicant
MEDICAL VISION AB
435 RICE CREEK TERRACE
FRIDLEY,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
MEDICAL VISION AB
435 RICE CREEK TERRACE
FRIDLEY,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/02/2009
Decision Date 02/24/2010
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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