MODEL GV-10 LANZ PRESSURE-VALVE

Tube, Tracheal (w/wo Connector)

EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Model Gv-10 Lanz Pressure-valve.

Pre-market Notification Details

Device IDK791045
510k NumberK791045
Device Name:MODEL GV-10 LANZ PRESSURE-VALVE
ClassificationTube, Tracheal (w/wo Connector)
Applicant EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-06-05
Decision Date1979-06-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60884522007448 K791045 000
60884522007431 K791045 000
60884522007424 K791045 000
40884522007413 K791045 000
60884522007400 K791045 000
60884522007394 K791045 000
60884522007387 K791045 000
40884522007376 K791045 000
60884522007363 K791045 000

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