SLIT CAMERA MODEL 07-624

Camera, Focal Spot, Radiographic

VICTOREEN, INC.

The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Slit Camera Model 07-624.

Pre-market Notification Details

Device IDK851811
510k NumberK851811
Device Name:SLIT CAMERA MODEL 07-624
ClassificationCamera, Focal Spot, Radiographic
Applicant VICTOREEN, INC. 100 VOICE RD. Carle Place,  NY  11514
ContactGlasser
CorrespondentGlasser
VICTOREEN, INC. 100 VOICE RD. Carle Place,  NY  11514
Product CodeIXH  
CFR Regulation Number892.1940 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-26
Decision Date1985-05-28

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