GUEDEL AIRWAYS

Tube, Tracheal (w/wo Connector)

LIFE SHIELD HEALTHCARE PRODUCTS, INC.

The following data is part of a premarket notification filed by Life Shield Healthcare Products, Inc. with the FDA for Guedel Airways.

Pre-market Notification Details

Device IDK932561
510k NumberK932561
Device Name:GUEDEL AIRWAYS
ClassificationTube, Tracheal (w/wo Connector)
Applicant LIFE SHIELD HEALTHCARE PRODUCTS, INC. 15381 STONY CREEK WAY Noblesville,  IN  46060
ContactTimothy Struthers
CorrespondentTimothy Struthers
LIFE SHIELD HEALTHCARE PRODUCTS, INC. 15381 STONY CREEK WAY Noblesville,  IN  46060
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-27
Decision Date1993-07-22

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