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510(k) K082908

NOVAGUARD, MODEL 3611001 by West Pharmaceutical Services, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2009
Date Received
September 30, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

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  • K123588 — INTRADERMAL ADAPTER (February 19, 2013)
  • K041691 — CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT (August 5, 2004)

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