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510(k) K141464

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

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

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  • 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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