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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stabilizer, Heart
510(k) Number K041338
FOIA Releasable 510(k) K041338
Device Name MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES
Applicant
Medtronic Vascular
7601 Northland Dr.
Brooklyn Park,  MN  55428
Applicant Contact SCOTT CUNDY
Correspondent
Medtronic Vascular
7601 Northland Dr.
Brooklyn Park,  MN  55428
Correspondent Contact SCOTT CUNDY
Regulation Number870.4500
Classification Product Code
MWS  
Date Received05/20/2004
Decision Date 07/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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