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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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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