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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 K132645
Device Name THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
Applicant
MEDTRONIC, INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Applicant Contact CHELSEA PIOSKE
Correspondent
MEDTRONIC, INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Correspondent Contact CHELSEA PIOSKE
Regulation Number878.4800
Classification Product Code
GAD  
Date Received08/23/2013
Decision Date 10/04/2013
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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