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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Contact 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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