TONGUE HOLDER/SALIVA EJECTOR

Mouthpiece, Saliva Ejector

UNITEK CORP.

The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Tongue Holder/saliva Ejector.

Pre-market Notification Details

Device IDK800210
510k NumberK800210
Device Name:TONGUE HOLDER/SALIVA EJECTOR
ClassificationMouthpiece, Saliva Ejector
Applicant UNITEK CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDYN  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-02-01
Decision Date1980-02-06

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