FDA 510(k) Application Details - K875147

Device Classification Name Tools, Pacemaker Service

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510(K) Number K875147
Device Name Tools, Pacemaker Service
Applicant CARDIAC PACEMAKERS, INC.
4100 HAMLINE AVE., NORTH
P.O. BOX 64079
ST. PAUL, MN US
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Contact GREG MATHISON
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Regulation Number 870.3730

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Classification Product Code DTF
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Date Received 12/15/1987
Decision Date 01/27/1988
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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