FDA 510(k) Application Details - K021990

Device Classification Name Wire, Guide, Catheter

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510(K) Number K021990
Device Name Wire, Guide, Catheter
Applicant GALT MEDICAL CORP.
2475 MERRITT DR.
GARLAND, TX 75041 US
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Contact DAVID CATLIN
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 06/18/2002
Decision Date 07/18/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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