5031 BRIGHT FLASH STIMULATOR

Photostimulator, Ac-powered

LIFE-TECH INTL., INC.

The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for 5031 Bright Flash Stimulator.

Pre-market Notification Details

Device IDK822915
510k NumberK822915
Device Name:5031 BRIGHT FLASH STIMULATOR
ClassificationPhotostimulator, Ac-powered
Applicant LIFE-TECH INTL., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHLX  
CFR Regulation Number886.1630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-10-01
Decision Date1982-12-28

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