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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 K890785
Device Name ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
Applicant
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112
Applicant Contact HELEN BUCKO
Correspondent
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112
Correspondent Contact HELEN BUCKO
Regulation Number870.3610
Classification Product Code
DXY  
Date Received02/15/1989
Decision Date 03/10/1989
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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