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FDA 510(k) Application Details - K020896
Device Classification Name
Pulse-Generator, Pacemaker, External
More FDA Info for this Device
510(K) Number
K020896
Device Name
Pulse-Generator, Pacemaker, External
Applicant
OSYPKA MEDICAL, INC.
7463 DRAPER AVE.
LA JOLLA, CA 92037 US
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Contact
MARKUS J OSYPKA
Other 510(k) Applications for this Contact
Regulation Number
870.3600
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Classification Product Code
DTE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/19/2002
Decision Date
06/14/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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