INTRADERMAL ADAPTER

Syringe, Piston

WEST PHARMACEUTICAL SERVICES, INC.

The following data is part of a premarket notification filed by West Pharmaceutical Services, Inc. with the FDA for Intradermal Adapter.

Pre-market Notification Details

Device IDK123588
510k NumberK123588
Device Name:INTRADERMAL ADAPTER
ClassificationSyringe, Piston
Applicant WEST PHARMACEUTICAL SERVICES, INC. 101 GORDON DR. Lionville,  PA  19341
ContactDebbie M Thomas
CorrespondentDebbie M Thomas
WEST PHARMACEUTICAL SERVICES, INC. 101 GORDON DR. Lionville,  PA  19341
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-21
Decision Date2013-02-19
Summary:summary

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