SURVIVAL KIT, INDIVIDUAL

General Surgery Tray

FRAASS SURVIVAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Fraass Survival Systems, Inc. with the FDA for Survival Kit, Individual.

Pre-market Notification Details

Device IDK871437
510k NumberK871437
Device Name:SURVIVAL KIT, INDIVIDUAL
ClassificationGeneral Surgery Tray
Applicant FRAASS SURVIVAL SYSTEMS, INC. 3830 BOSTON RD. Bronx,  NY  10475
ContactPatrick A Malia
CorrespondentPatrick A Malia
FRAASS SURVIVAL SYSTEMS, INC. 3830 BOSTON RD. Bronx,  NY  10475
Product CodeLRO  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-13
Decision Date1987-07-09

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