510(k) K141464

NOVAGUARD S A SAFETY SYSTEM by West Pharmaceutical Services — Product Code MEG

K141464 is an FDA 510(k) premarket notification submitted by West Pharmaceutical Services for the device "NOVAGUARD S A SAFETY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 10, 2014. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. West Pharmaceutical Services has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2014
Date Received
June 3, 2014
Clearance Type
Traditional
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