510(k) K163511

NovaGuard SA Pro Safety System by West Pharmaceutical Services, Inc. — Product Code MEG

K163511 is an FDA 510(k) premarket notification submitted by West Pharmaceutical Services, Inc. for the device "NovaGuard SA Pro Safety System". The FDA issued a decision of Substantially Equivalent on February 2, 2017. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. West Pharmaceutical Services, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2017
Date Received
December 15, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Antistick
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type