NUCLEAR ASSOCIATES GLASSERS

Shield, Eye, Radiological

VICTOREEN, INC.

The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Nuclear Associates Glassers.

Pre-market Notification Details

Device IDK934362
510k NumberK934362
Device Name:NUCLEAR ASSOCIATES GLASSERS
ClassificationShield, Eye, Radiological
Applicant VICTOREEN, INC. 6000 COCHRAN RD. Solon,  OH  44139 -3395
ContactChristine L Jess
CorrespondentChristine L Jess
VICTOREEN, INC. 6000 COCHRAN RD. Solon,  OH  44139 -3395
Product CodeIWS  
CFR Regulation Number892.6500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-08
Decision Date1993-11-12

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