FDA 510(k) Application Details - K991560

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K991560
Device Name Nasopharyngoscope (Flexible Or Rigid)
Applicant FIBER IMAGING TECHNOLOGIES, INC.
45 PONTIAC RD.
NEWTON, MA 02468 US
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Contact JOSEPH RESS
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Regulation Number 874.4760

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Classification Product Code EOB
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Date Received 05/04/1999
Decision Date 07/13/1999
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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