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510(k) K163511

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

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

Other clearances by West Pharmaceutical Services, Inc.

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  • K141464 — NOVAGUARD S A SAFETY SYSTEM (September 10, 2014)
  • K123588 — INTRADERMAL ADAPTER (February 19, 2013)
  • K082908 — NOVAGUARD, MODEL 3611001 (April 24, 2009)
  • K041691 — CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT (August 5, 2004)

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