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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 K971059
Device Name UNIVERSAL DRIVE SYSTEM
Applicant
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773 -4908
Applicant Contact CAROL A WEIDEMAN
Correspondent
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773 -4908
Correspondent Contact CAROL A WEIDEMAN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/24/1997
Decision Date 06/18/1997
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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