TOUCH TALKER

System, Communication, Powered

PRENTKE ROMICH CO.

The following data is part of a premarket notification filed by Prentke Romich Co. with the FDA for Touch Talker.

Pre-market Notification Details

Device IDK914259
510k NumberK914259
Device Name:TOUCH TALKER
ClassificationSystem, Communication, Powered
Applicant PRENTKE ROMICH CO. 1022 HEYL RD. Wooster,  OH  44691
ContactMichael L Molter
CorrespondentMichael L Molter
PRENTKE ROMICH CO. 1022 HEYL RD. Wooster,  OH  44691
Product CodeILQ  
CFR Regulation Number890.3710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-23
Decision Date1992-02-27

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