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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K842780
Device Name MEDTRONIC 6210 PERMANENT LEAD INTRODUC
Applicant
MEDTRONIC VASCULAR
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDTRONIC VASCULAR
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/16/1984
Decision Date 08/03/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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