ULTRA-WIDE SAFETY SPECTACLE FRAME

Frame, Spectacle

ZEE MEDICAL PRODUCTS CO., INC.

The following data is part of a premarket notification filed by Zee Medical Products Co., Inc. with the FDA for Ultra-wide Safety Spectacle Frame.

Pre-market Notification Details

Device IDK813156
510k NumberK813156
Device Name:ULTRA-WIDE SAFETY SPECTACLE FRAME
ClassificationFrame, Spectacle
Applicant ZEE MEDICAL PRODUCTS CO., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHQZ  
CFR Regulation Number886.5842 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-06
Decision Date1981-12-14

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