FDA 510(k) Application Details - K142695

Device Classification Name Esophagoscope (Flexible Or Rigid)

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510(K) Number K142695
Device Name Esophagoscope (Flexible Or Rigid)
Applicant Covidien LLC
15 HAMPSHIRE ST
MANSFIELD, MA 02048 US
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Contact Richelle Hover
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Regulation Number 874.4710

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Classification Product Code EOX
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Date Received 09/22/2014
Decision Date 11/26/2014
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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