NON REBREATHING VALVE

Valve, Non-rebreathing

SPECIALTY PACKAGING PRODUCS, INC.

The following data is part of a premarket notification filed by Specialty Packaging Producs, Inc. with the FDA for Non Rebreathing Valve.

Pre-market Notification Details

Device IDK913163
510k NumberK913163
Device Name:NON REBREATHING VALVE
ClassificationValve, Non-rebreathing
Applicant SPECIALTY PACKAGING PRODUCS, INC. 19 LEIGH FISHER El Paso,  TX  79906
ContactEdward F Valdez
CorrespondentEdward F Valdez
SPECIALTY PACKAGING PRODUCS, INC. 19 LEIGH FISHER El Paso,  TX  79906
Product CodeCBP  
CFR Regulation Number868.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-17
Decision Date1992-02-03

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