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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, ultraviolet, dermatological
510(k) Number K220840
Device Name 1 Series Phototherapy Equipment
Applicant
Daavlin Distributing Co.
205 West Bement Street
Bryan,  OH  43506
Applicant Contact Michele Thiel
Correspondent
Daavlin Distributing Co.
205 West Bement Street
Bryan,  OH  43506
Correspondent Contact Michele Thiel
Regulation Number878.4630
Classification Product Code
FTC  
Date Received03/23/2022
Decision Date 04/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
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