FDA 510(k) Application Details - K221660

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K221660
Device Name Nasopharyngoscope (Flexible Or Rigid)
Applicant Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi 192-8507 JP
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Contact Shinichiro Kawachi
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Regulation Number 874.4760

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Classification Product Code EOB
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Date Received 06/08/2022
Decision Date 12/28/2022
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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