WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT

Camera, Cine, Endoscopic, Without Audio

WELLS JOHNSON CO.

The following data is part of a premarket notification filed by Wells Johnson Co. with the FDA for Weco Endoscopic System With Fiber Optic Light.

Pre-market Notification Details

Device IDK951519
510k NumberK951519
Device Name:WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT
ClassificationCamera, Cine, Endoscopic, Without Audio
Applicant WELLS JOHNSON CO. 8075 E RESEARCH CT., STE. 101 P.O. BOX 18230 Tucson,  AZ  85731 -8230
ContactBrenda Hunt
CorrespondentBrenda Hunt
WELLS JOHNSON CO. 8075 E RESEARCH CT., STE. 101 P.O. BOX 18230 Tucson,  AZ  85731 -8230
Product CodeFWL  
CFR Regulation Number878.4160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-03
Decision Date1995-06-14

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