LEAD PLASTIC VIEWING PANELS

Screen, Leaded, Operator Radiation Protector

VICTOREEN, INC.

The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Lead Plastic Viewing Panels.

Pre-market Notification Details

Device IDK850816
510k NumberK850816
Device Name:LEAD PLASTIC VIEWING PANELS
ClassificationScreen, Leaded, Operator Radiation Protector
Applicant VICTOREEN, INC. 100 VOICE RD. Carle Place,  NY  11514
ContactGlasser
CorrespondentGlasser
VICTOREEN, INC. 100 VOICE RD. Carle Place,  NY  11514
Product CodeEAK  
CFR Regulation Number892.6500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-28
Decision Date1985-04-10

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