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FDA 510(k) Application Details - K955722
Device Classification Name
Electrode, Pacemaker, Temporary
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510(K) Number
K955722
Device Name
Electrode, Pacemaker, Temporary
Applicant
DAVIS & GECK, INC.
ONE CASPER ST.
DANBURY, CT 06810 US
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Contact
STEPHEN J TAMSETT
Other 510(k) Applications for this Contact
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
12/18/1995
Decision Date
03/15/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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