DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE

Syringe, Piston

DEVON SAFETY PRODUCTS, INC.

The following data is part of a premarket notification filed by Devon Safety Products, Inc. with the FDA for Devon Standard Syringe, Hypodermic Needle And Insulin Syringe.

Pre-market Notification Details

Device IDK052551
510k NumberK052551
Device Name:DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE
ClassificationSyringe, Piston
Applicant DEVON SAFETY PRODUCTS, INC. 1100 FIRST AVE., SUITE 100 King Of Prussia,  PA  19406
ContactBarry L Berler
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-09-16
Decision Date2005-09-30
Summary:summary

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