FDA 510(k) Application Details - K101479

Device Classification Name Catheter, Percutaneous

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510(K) Number K101479
Device Name Catheter, Percutaneous
Applicant REFLOW MEDICAL
5311 FOXHOUND WAY
SAN DIEGO, CA 92130 US
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Contact REBECCA PINE
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 05/28/2010
Decision Date 08/11/2010
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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