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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
Applicant Contact ANN MORRISSEY
Correspondent
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112
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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