CPR MICROMASK

Valve, Non-rebreathing

PLASCO, INC.

The following data is part of a premarket notification filed by Plasco, Inc. with the FDA for Cpr Micromask.

Pre-market Notification Details

Device IDK951483
510k NumberK951483
Device Name:CPR MICROMASK
ClassificationValve, Non-rebreathing
Applicant PLASCO, INC. 4080 MORRISON DR. Gurnee,  IL  60031
ContactGary S Botsford
CorrespondentGary S Botsford
PLASCO, INC. 4080 MORRISON DR. Gurnee,  IL  60031
Product CodeCBP  
CFR Regulation Number868.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-30
Decision Date1995-10-19

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