WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

Tube, Tracheostomy (w/wo Connector)

REGULATORY AND MARKETING SERVICES, INC.

The following data is part of a premarket notification filed by Regulatory And Marketing Services, Inc. with the FDA for Well Lead Tracheostomy Tube And Disposable Inner Cannula.

Pre-market Notification Details

Device IDK101721
510k NumberK101721
Device Name:WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
ClassificationTube, Tracheostomy (w/wo Connector)
Applicant REGULATORY AND MARKETING SERVICES, INC. 962 ALLEGRO LANE Apollo Beach,  FL  33572
ContactArthur Ward
CorrespondentArthur Ward
REGULATORY AND MARKETING SERVICES, INC. 962 ALLEGRO LANE Apollo Beach,  FL  33572
Product CodeBTO  
CFR Regulation Number868.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-18
Decision Date2011-03-24
Summary:summary

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