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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 K212510
Device Name 7 Series Phototherapy Device
Applicant
Daavlin Distributing Co.
205 W. Bement Street
Bryan,  OH  43506
Applicant Contact Michele Thiel
Correspondent
Daavlin Distributing Co.
205 W. Bement Street
Bryan,  OH  43506
Correspondent Contact Michele Thiel
Regulation Number878.4630
Classification Product Code
FTC  
Date Received08/10/2021
Decision Date 11/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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