TRACHEOSTOMY CARE KIT

Tube, Tracheostomy (w/wo Connector)

PACO RESEARCH CORP.

The following data is part of a premarket notification filed by Paco Research Corp. with the FDA for Tracheostomy Care Kit.

Pre-market Notification Details

Device IDK850446
510k NumberK850446
Device Name:TRACHEOSTOMY CARE KIT
ClassificationTube, Tracheostomy (w/wo Connector)
Applicant PACO RESEARCH CORP. ELLIS PHARMACEUTICAL CONSULTIN 913 STATE ROAD Princeton,  NJ  08540
ContactLevi Ellis
CorrespondentLevi Ellis
PACO RESEARCH CORP. ELLIS PHARMACEUTICAL CONSULTIN 913 STATE ROAD Princeton,  NJ  08540
Product CodeBTO  
CFR Regulation Number868.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-05
Decision Date1985-03-11

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