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FDA 510(k) Application Details - K971775
Device Classification Name
Electrode, Pacemaker, Temporary
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510(K) Number
K971775
Device Name
Electrode, Pacemaker, Temporary
Applicant
CARDIAC CONTROL SYSTEMS, INC.
3 COMMERCE BLVD.
PALM COAST, FL 32164 US
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Contact
TERRY C MCMAHON
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Regulation Number
870.3680
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Classification Product Code
LDF
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More FDA Info for this Product Code
Date Received
05/13/1997
Decision Date
12/29/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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