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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 K040483
Device Name EQUESTRA FLUID DELIVERY SYSTEM
Applicant
Medtronic Sofamor Danek, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact RICHARD TREHARNE
Correspondent
Medtronic Sofamor Danek, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact RICHARD TREHARNE
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
HXG  
Date Received02/25/2004
Decision Date 07/23/2004
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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