FDA 510(k) Application Details - K841926

Device Classification Name Wire, Guide, Catheter

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510(K) Number K841926
Device Name Wire, Guide, Catheter
Applicant ARGON MEDICAL CORP.
P.O. BOX 1970
ATHENS, TX US
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Contact VAN HINE
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 05/10/1984
Decision Date 01/02/1985
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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