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FDA 510(k) Application Details - K070448
Device Classification Name
Sensor, Pressure, Aneurysm, Implantable
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510(K) Number
K070448
Device Name
Sensor, Pressure, Aneurysm, Implantable
Applicant
CARDIOMEMS INC
75 FIFTH ST., NW
SUITE 440
ATLANTA, GA 30308 US
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GRACE POWERS
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Regulation Number
870.2855
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Classification Product Code
NQH
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Date Received
02/15/2007
Decision Date
03/15/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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