MORELL INJECTOR

Anesthesia Conduction Kit

INCUTECH, INC.

The following data is part of a premarket notification filed by Incutech, Inc. with the FDA for Morell Injector.

Pre-market Notification Details

Device IDK951870
510k NumberK951870
Device Name:MORELL INJECTOR
ClassificationAnesthesia Conduction Kit
Applicant INCUTECH, INC. 307-A SOUTH WESTGATE DR. Greensboro,  NC  27407
ContactRoger V Molina
CorrespondentRoger V Molina
INCUTECH, INC. 307-A SOUTH WESTGATE DR. Greensboro,  NC  27407
Product CodeCAZ  
CFR Regulation Number868.5140 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-21
Decision Date1996-01-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.