FDA 510(k) Application Details - K962116

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K962116
Device Name Nasopharyngoscope (Flexible Or Rigid)
Applicant GALILEO ELECTRO-OPTICS CORP.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact MARY MCNARMARA-CULLINANE
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Regulation Number 874.4760

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Classification Product Code EOB
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Date Received 05/31/1996
Decision Date 11/27/1996
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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