MOUTH STICK KIT

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 Mouth Stick Kit.

Pre-market Notification Details

Device IDK823625
510k NumberK823625
Device Name:MOUTH STICK KIT
ClassificationSystem, Communication, Non-powered
Applicant FRED SAMMONS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeILP  
CFR Regulation Number890.3700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-06
Decision Date1982-12-30

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