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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K842394
Device Name ASTRA 2, ASTRA 3, 4 & 6
Applicant
Cardiac Pacemakers, Inc.
P.O. Box 43079
St. Paul,  MN  55164 -
Applicant Contact ANN MORRISSEY
Correspondent
Cardiac Pacemakers, Inc.
P.O. Box 43079
St. Paul,  MN  55164 -
Correspondent Contact ANN MORRISSEY
Regulation Number870.3610
Classification Product Code
DXY  
Date Received06/19/1984
Decision Date 10/17/1984
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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