7 Series Phototherapy Device

Light, Ultraviolet, Dermatological

Daavlin Distributing Co.

The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for 7 Series Phototherapy Device.

Pre-market Notification Details

Device IDK212510
510k NumberK212510
Device Name:7 Series Phototherapy Device
ClassificationLight, Ultraviolet, Dermatological
Applicant Daavlin Distributing Co. 205 W. Bement Street Bryan,  OH  43506
ContactMichele Thiel
CorrespondentMichele Thiel
Daavlin Distributing Co. 205 W. Bement Street Bryan,  OH  43506
Product CodeFTC  
CFR Regulation Number878.4630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-10
Decision Date2021-11-04

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