The following data is part of a premarket notification filed by West Pharmaceutical Services Inc. with the FDA for Intradermal Adapter.
Device ID | K151777 |
510k Number | K151777 |
Device Name: | Intradermal Adapter |
Classification | Syringe, Piston |
Applicant | WEST PHARMACEUTICAL SERVICES INC. 530 HERMAN O. WEST DRIVE Exton, PA 19341 |
Contact | Jeffrey Ravel |
Correspondent | Jeffrey Ravel WEST PHARMACEUTICAL SERVICES INC. 530 HERMAN O. WEST DRIVE Exton, 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 | 2015-07-01 |
Decision Date | 2015-09-29 |
Summary: | summary |