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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Autofluorescence Imaging Adjunct Tool For Wounds
510(k) Number K211901
Device Name MolecuLightDX
Applicant
Moleculight, Inc.
Suite 700, 425 University Ave.
Toronto,  CA M5G 1T6
Applicant Contact Jordan John
Correspondent
Moleculight, Inc.
Suite 700, 425 University Ave.
Toronto,  CA M5G 1T6
Correspondent Contact Jordan John
Regulation Number878.4550
Classification Product Code
QJF  
Date Received06/21/2021
Decision Date 07/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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