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FDA 510(k) Application Details - K991293
Device Classification Name
Generator, Pulse, Pacemaker, External Programmable
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510(K) Number
K991293
Device Name
Generator, Pulse, Pacemaker, External Programmable
Applicant
FISCHER MEDICAL TECHNOLOGIES, INC.
12300 NORTH GRANT
DENVER, CO 80241 US
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Contact
RONALD SHORES
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Regulation Number
870.1750
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Classification Product Code
JOQ
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More FDA Info for this Product Code
Date Received
04/15/1999
Decision Date
05/05/2000
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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