BITE-BLOCK

Support, Breathing Tube

SONTEK INDUSTRIES, INC.

The following data is part of a premarket notification filed by Sontek Industries, Inc. with the FDA for Bite-block.

Pre-market Notification Details

Device IDK833374
510k NumberK833374
Device Name:BITE-BLOCK
ClassificationSupport, Breathing Tube
Applicant SONTEK INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJAY  
CFR Regulation Number868.5280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-27
Decision Date1983-11-03

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