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 IDK151777
510k NumberK151777
Device Name:Intradermal Adapter
ClassificationSyringe, Piston
Applicant WEST PHARMACEUTICAL SERVICES INC. 530 HERMAN O. WEST DRIVE Exton,  PA  19341
ContactJeffrey Ravel
CorrespondentJeffrey Ravel
WEST PHARMACEUTICAL SERVICES INC. 530 HERMAN O. WEST DRIVE Exton,  PA  19341
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-01
Decision Date2015-09-29
Summary:summary

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