PULM O2 SUCTION CATHETER TRAYS

Catheters, Suction, Tracheobronchial

PREMIUM PLASTICS, INC.

The following data is part of a premarket notification filed by Premium Plastics, Inc. with the FDA for Pulm O2 Suction Catheter Trays.

Pre-market Notification Details

Device IDK953226
510k NumberK953226
Device Name:PULM O2 SUCTION CATHETER TRAYS
ClassificationCatheters, Suction, Tracheobronchial
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 CodeBSY  
CFR Regulation Number868.6810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-06
Decision Date1995-08-08

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