FDA 510(k) Application Details - K972923

Device Classification Name Protector, Hearing (Insert)

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510(K) Number K972923
Device Name Protector, Hearing (Insert)
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 000.0000

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Classification Product Code EWD
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Date Received 08/08/1997
Decision Date 10/27/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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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