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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pulse-Generator, Pacemaker, External
510(k) Number K782108
Device Name MEDTRONIC MODEL 546
Applicant
Medtronic Vascular
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Medtronic Vascular
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.3600
Classification Product Code
DTE  
Date Received12/19/1978
Decision Date 12/29/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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