GENT-L-KARE TRACHEOSTOMY TRAYS

Tracheostomy And Nasal Suctioning Kit

PREMIUM PLASTICS, INC.

The following data is part of a premarket notification filed by Premium Plastics, Inc. with the FDA for Gent-l-kare Tracheostomy Trays.

Pre-market Notification Details

Device IDK950851
510k NumberK950851
Device Name:GENT-L-KARE TRACHEOSTOMY TRAYS
ClassificationTracheostomy And Nasal Suctioning Kit
Applicant PREMIUM PLASTICS, INC. 465 WEST CERMAK RD. Chicago,  IL  60616
ContactGary Garbin
CorrespondentGary Garbin
PREMIUM PLASTICS, INC. 465 WEST CERMAK RD. Chicago,  IL  60616
Product CodeLRQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-24
Decision Date1995-06-21

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