MINOR SURGERY LIGHT MODEL 2112

Light, Surgical, Floor Standing

ADEL MEDICAL LTD.

The following data is part of a premarket notification filed by Adel Medical Ltd. with the FDA for Minor Surgery Light Model 2112.

Pre-market Notification Details

Device IDK860020
510k NumberK860020
Device Name:MINOR SURGERY LIGHT MODEL 2112
ClassificationLight, Surgical, Floor Standing
Applicant ADEL MEDICAL LTD. 16700 S.E. 120TH AVE. P.O. BOX 542 Clackamas,  OR  97015
ContactDave Cole
CorrespondentDave Cole
ADEL MEDICAL LTD. 16700 S.E. 120TH AVE. P.O. BOX 542 Clackamas,  OR  97015
Product CodeFSS  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-03
Decision Date1986-01-24

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