SMART TOUCH UVTHERAPY MULTIPLE MACHINE

Light, Ultraviolet, Dermatological

DAAVLIN DISTRIBUTING CO.

The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for Smart Touch Uvtherapy Multiple Machine.

Pre-market Notification Details

Device IDK110912
510k NumberK110912
Device Name:SMART TOUCH UVTHERAPY MULTIPLE MACHINE
ClassificationLight, Ultraviolet, Dermatological
Applicant DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan,  OH  43506
ContactMichele Thiel
CorrespondentMichele Thiel
DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan,  OH  43506
Product CodeFTC  
CFR Regulation Number878.4630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-01
Decision Date2011-10-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B280861PH4800MMPC60 K110912 000
B280861PH2424MMPC60 K110912 000
B280861PH0048MMPC60 K110912 000
B280861PH0024MMPC60 K110912 000
B280803MI0604MMPC60 K110912 000
B280801MI1000MMPC60 K110912 000
B280801MI0604MMPC60 K110912 000
B280801MI0010MMPC60 K110912 000

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