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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nasopharyngoscope (flexible or rigid)
510(k) Number K173855
Device Name Sharpsite AC Rigid Endsocope
Applicant
Medtronic Xomed Inc.
6743 Southpoint Drive North
Jacksonville,  FL  32216
Applicant Contact Shravan Chawla
Correspondent
Medtronic Xomed Inc.
6743 Southpoint Drive North
Jacksonville,  FL  32216
Correspondent Contact Shravan Chawla
Regulation Number874.4760
Classification Product Code
EOB  
Date Received12/20/2017
Decision Date 04/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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