TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)

Tube, Tracheostomy (w/wo Connector)

AMERICAN HEALTHCARE CORP.

The following data is part of a premarket notification filed by American Healthcare Corp. with the FDA for Tracheostomy Care Set W/extra Towel(ahc-20-54686).

Pre-market Notification Details

Device IDK924194
510k NumberK924194
Device Name:TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)
ClassificationTube, Tracheostomy (w/wo Connector)
Applicant AMERICAN HEALTHCARE CORP. ONE AMERICAN HEALTHCARE PLAZA 3611 KENNEDY ROAD South Plainfield,  NJ  07080
ContactRalph S Jarrett
CorrespondentRalph S Jarrett
AMERICAN HEALTHCARE CORP. ONE AMERICAN HEALTHCARE PLAZA 3611 KENNEDY ROAD South Plainfield,  NJ  07080
Product CodeBTO  
CFR Regulation Number868.5800 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-20
Decision Date1993-01-06

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