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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name retractor
510(k) Number K043602
Device Name QUADRANT RETRACTOR SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Applicant Contact RICHARD TREHARNE
Correspondent
MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Correspondent Contact RICHARD TREHARNE
Regulation Number878.4800
Classification Product Code
GAD  
Subsequent Product Codes
FSZ   NBH  
Date Received12/29/2004
Decision Date 02/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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