FDA 510(k) Application Details - K202727

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K202727
Device Name Nasopharyngoscope (Flexible Or Rigid)
Applicant 3NT Medical Ltd.
22 HaMelacha St., POB 11384
Rosh Ha'Ayin 4809169 IL
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Contact Ehud Bendory
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Regulation Number 874.4760

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Classification Product Code EOB
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Date Received 09/17/2020
Decision Date 07/23/2021
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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