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FDA 510(k) Application Details - K012404
Device Classification Name
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
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510(K) Number
K012404
Device Name
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Applicant
KATECHO, INC.
2500 BELL AVE.
P.O. BOX 21247
DES MOINES, IA 50321 US
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Contact
WARREN R WALTERS
Other 510(k) Applications for this Contact
Regulation Number
870.5550
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Classification Product Code
DRO
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More FDA Info for this Product Code
Date Received
07/30/2001
Decision Date
10/12/2001
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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