FDA 510(k) Application Details - K920884

Device Classification Name Wire, Guide, Catheter

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510(K) Number K920884
Device Name Wire, Guide, Catheter
Applicant ACME-MONACO CORP.
26468 ASBURY AVE.
CRISFIELD, MD US
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Contact HERBERT CARTER
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 01/02/1992
Decision Date 08/19/1992
Decision SE - Substantially Equivalent
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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