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FDA 510(k) Application Details - K120178
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K120178
Device Name
Catheter, Percutaneous
Applicant
REFLOW MEDICAL
1003 Calle Sombra
San Clemente, CA 92673 US
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Contact
Rebecca K Pine
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
01/20/2012
Decision Date
02/08/2012
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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