FDA 510(k) Application Details - K955704

Device Classification Name Bur, Ear, Nose And Throat

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510(K) Number K955704
Device Name Bur, Ear, Nose And Throat
Applicant TREBAY MEDICAL CORP.
4911 CREEKSIDE DR.
CLEARWATER, FL 34620 US
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Contact DAN H TREACE
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Regulation Number 874.4140

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Classification Product Code EQJ
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Date Received 12/15/1995
Decision Date 01/30/1996
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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