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FDA 510(k) Application Details - K052209
Device Classification Name
Flowmeter, Blood, Cardiovascular
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510(K) Number
K052209
Device Name
Flowmeter, Blood, Cardiovascular
Applicant
VASCULAR CONTROL SYSTEMS, INC
32236 PASEO ADELANTO, STE. F
SAN JUAN CAPISTRANO, CA 92675 US
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Contact
KATHLEEN ROBERTS
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Regulation Number
870.2100
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Classification Product Code
DPW
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More FDA Info for this Product Code
Date Received
08/15/2005
Decision Date
09/06/2005
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
Y
Expedited Review
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