FDA 510(k) Application Details - K082174

Device Classification Name Bronchoscope Accessory

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510(K) Number K082174
Device Name Bronchoscope Accessory
Applicant ASTHMATX, INC.
888 ROSS DRIVE
SUNNYVALE, CA 94089 US
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Contact CARTER NAVARRO
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Regulation Number 874.4680

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Classification Product Code KTI
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Date Received 08/01/2008
Decision Date 10/20/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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