EUROMEDICAL POLY TRACHEOTOMY TUBE

Tube Tracheostomy And Tube Cuff

REGULATORY & MARKETING SERVICES, INC.

The following data is part of a premarket notification filed by Regulatory & Marketing Services, Inc. with the FDA for Euromedical Poly Tracheotomy Tube.

Pre-market Notification Details

Device IDK945874
510k NumberK945874
Device Name:EUROMEDICAL POLY TRACHEOTOMY TUBE
ClassificationTube Tracheostomy And Tube Cuff
Applicant REGULATORY & MARKETING SERVICES, INC. P.O. BOX 2308 1247 FLORIDA AVENUE Palm Harbor,  FL  34682 -2308
ContactPatrick J Lamb
CorrespondentPatrick J Lamb
REGULATORY & MARKETING SERVICES, INC. P.O. BOX 2308 1247 FLORIDA AVENUE Palm Harbor,  FL  34682 -2308
Product CodeJOH  
CFR Regulation Number868.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-01
Decision Date1994-12-27

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