LARYNGOSCOPE BLADES

Laryngoscope, Rigid

TRUPHATEK, LTD.

The following data is part of a premarket notification filed by Truphatek, Ltd. with the FDA for Laryngoscope Blades.

Pre-market Notification Details

Device IDK883414
510k NumberK883414
Device Name:LARYNGOSCOPE BLADES
ClassificationLaryngoscope, Rigid
Applicant TRUPHATEK, LTD. P.O. BOX 8051 Netanya,  IL 42106
ContactDavid Grey
CorrespondentDavid Grey
TRUPHATEK, LTD. P.O. BOX 8051 Netanya,  IL 42106
Product CodeCCW  
CFR Regulation Number868.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-15
Decision Date1988-08-19

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