FDA 510(k) Application Details - K143673

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K143673
Device Name Nasopharyngoscope (Flexible Or Rigid)
Applicant Schoelly Fiberoptic Gmbh
Robert-Bosch-Str. 1-3
Denzlingen 79211 DE
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Contact Dr. Sandra Baumann
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Regulation Number 874.4760

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Classification Product Code EOB
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Date Received 12/24/2014
Decision Date 03/04/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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