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FDA 510(k) Application Details - K030852
Device Classification Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
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510(K) Number
K030852
Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant
MOGUL ENTERPRISES
6387 SAN IGNACIO AVE.
SAN JOSE, CA 95119 US
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Contact
JAMIL MOGUL
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Regulation Number
870.1220
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Classification Product Code
DRF
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More FDA Info for this Product Code
Date Received
03/18/2003
Decision Date
07/10/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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