KIT OF WORDS & LTRS TO RE-LEARN-BK4014

System, Communication, Non-powered

FRED SAMMONS, INC.

The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Kit Of Words & Ltrs To Re-learn-bk4014.

Pre-market Notification Details

Device IDK823609
510k NumberK823609
Device Name:KIT OF WORDS & LTRS TO RE-LEARN-BK4014
ClassificationSystem, Communication, Non-powered
Applicant FRED SAMMONS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeILP  
CFR Regulation Number890.3700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-06
Decision Date1982-12-22

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