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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 K063326
Device Name CONMED LINVATEC 24K IRRIGATION SYSTEM
Applicant
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact SUE F DAUTERMAN
Correspondent
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact SUE F DAUTERMAN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/03/2006
Decision Date 01/31/2007
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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