IMAGE DEFLECTOR

Frame, Trial, Ophthalmic

MICHAEL ONUFRYK

The following data is part of a premarket notification filed by Michael Onufryk with the FDA for Image Deflector.

Pre-market Notification Details

Device IDK833669
510k NumberK833669
Device Name:IMAGE DEFLECTOR
ClassificationFrame, Trial, Ophthalmic
Applicant MICHAEL ONUFRYK 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHPA  
CFR Regulation Number886.1415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-10-18
Decision Date1984-03-27

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