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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device System, Imaging, Tympanic Membrane And Middle Ear
510(k) Number K222655
Device Name OtoSight Middle Ear Scope
Applicant
PhotoniCare, Inc
1902 Fox Drive, Suite F
Champaign,  IL  61820
Applicant Contact Ryan Shelton
Correspondent
PhotoniCare, Inc
1902 Fox Drive, Suite F
Champaign,  IL  61820
Correspondent Contact Ryan Shelton
Regulation Number892.1560
Classification Product Code
QJG  
Date Received09/02/2022
Decision Date 09/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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