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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 K191804
Device Name TOMi Scope
Applicant
Photonicare, Inc.
60 Hazelwood Dr.
Champaign,  IL  61820
Applicant Contact Ryan Shelton
Correspondent
Photonicare, Inc.
60 Hazelwood Dr.
Champaign,  IL  61820
Correspondent Contact Ryan Shelton
Regulation Number892.1560
Classification Product Code
QJG  
Date Received07/05/2019
Decision Date 12/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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