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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K863000
Device Name ASTRA 2,3,4 AND 6: CHIP REVISION
Applicant
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112 -5798
Applicant Contact ANN MORRISSEY
Correspondent
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112 -5798
Correspondent Contact ANN MORRISSEY
Date Received08/08/1986
Decision Date 08/19/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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