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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 K200609
Device Name ENTity WiFi Video Nasopharyngoscope System
Applicant
Optim, LLC
64 Technology Park Rd.
Sturbridge,  MA  01566
Applicant Contact Jenna Lipka
Correspondent
Delphi Medical Device Consulting, Inc.
5 Whitcomb Ave.
Ayer,  MA  01432
Correspondent Contact Pamela Papineau
Regulation Number874.4760
Classification Product Code
EOB  
Date Received03/09/2020
Decision Date 01/13/2021
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
Predetermined Change
Control Plan Authorized		 No
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