FDA 510(k) Application Details - K022316

Device Classification Name Catheter, Recording, Electrode, Reprocessed

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510(K) Number K022316
Device Name Catheter, Recording, Electrode, Reprocessed
Applicant VANGUARD MEDICAL CONCEPTS, INC.
5307 GREAT OAK DR.
LAKELAND, FL 33815 US
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Contact MIKE SAMMON
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Regulation Number 870.1220

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Classification Product Code NLH
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Date Received 07/17/2002
Decision Date 10/10/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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