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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 K093471
Device Name KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP
Applicant
Karl Storz Endoscopy-America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Applicant Contact CRYSTAL DIZOL
Correspondent
Karl Storz Endoscopy-America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Correspondent Contact CRYSTAL DIZOL
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/06/2009
Decision Date 10/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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