3 SERIES PHOTOTHERAPY CABINET

Light, Ultraviolet, Dermatological

DAAVLIN CO.

The following data is part of a premarket notification filed by Daavlin Co. with the FDA for 3 Series Phototherapy Cabinet.

Pre-market Notification Details

Device IDK063621
510k NumberK063621
Device Name:3 SERIES PHOTOTHERAPY CABINET
ClassificationLight, Ultraviolet, Dermatological
Applicant DAAVLIN CO. 205 WEST BEMENT ST. P.O. BOX 626 Bryan,  OH  43506
ContactTara Mansur
CorrespondentTara Mansur
DAAVLIN CO. 205 WEST BEMENT ST. P.O. BOX 626 Bryan,  OH  43506
Product CodeFTC  
CFR Regulation Number878.4630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-05
Decision Date2007-01-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B280862PM0048PC60 K063621 000
B2809861PH2424PC5 K063621 000
B2809861PH2424PC3 K063621 000
B2809861PH0048SP6 K063621 000
B2809861PH0048SP5 K063621 000
B2809861PH0048SP3 K063621 000
B2809861PH0048PC6220 K063621 000
B2809861PH0048PC6 K063621 000
B2809861PH0048PC5 K063621 000
B2809861PH0024PC6 K063621 000
B2809861PH2424PC6 K063621 000
B2809861PH2424PC6220 K063621 000
B2809861PH4800PC5 K063621 000
B280861PH4800SP60 K063621 000
B280861PH4800PC60 K063621 000
B280861PH2424SP60 K063621 000
B280861PH2424PC60 K063621 000
B280861PH0048SP60 K063621 000
B280861PH0048PC60 K063621 000
B280861PH0024SP60 K063621 000
B280861PH0024PC60 K063621 000
B2809861PH4800PC6 K063621 000
B2809861PH0024PC5 K063621 000

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