FDA 510(k) Application Details - K972922

Device Classification Name Balloon, Epistaxis

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510(K) Number K972922
Device Name Balloon, Epistaxis
Applicant INTERVIEW MEDICAL TECHNOLOGY CORP.
3941 PARK DR., SUITE 20-325
EL DORADO HILLS, CA 95762 US
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Contact LOU MATSON
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Regulation Number 874.4100

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Classification Product Code EMX
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Date Received 08/08/1997
Decision Date 10/08/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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