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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 K983652
Device Name ABLATOR ELECTRODE
Applicant
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773 -4908
Applicant Contact LAURA D SENEFF
Correspondent
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773 -4908
Correspondent Contact LAURA D SENEFF
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GEI  
Date Received10/19/1998
Decision Date 03/23/1999
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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