The following data is part of a premarket notification filed by West Pharmaceutical Services, Inc. with the FDA for Intradermal Adapter.
Device ID | K123588 |
510k Number | K123588 |
Device Name: | INTRADERMAL ADAPTER |
Classification | Syringe, Piston |
Applicant | WEST PHARMACEUTICAL SERVICES, INC. 101 GORDON DR. Lionville, PA 19341 |
Contact | Debbie M Thomas |
Correspondent | Debbie M Thomas WEST PHARMACEUTICAL SERVICES, INC. 101 GORDON DR. Lionville, PA 19341 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-21 |
Decision Date | 2013-02-19 |
Summary: | summary |