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510(k) K041232

GETTIG UNIVERSAL VIAL ACCESS PIN by Gettig Pharmaceutical Instrument Co. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2004
Date Received
May 10, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Gettig Pharmaceutical Instrument Co.

  • K033409 — AMERSHAM HEALTH NEEDLE-GUARD (January 21, 2004)
  • K022495 — GETTIG DISPOSABLE SYRINGES (October 8, 2002)
  • K000455 — GETTIG GUARD (April 19, 2000)
  • K972285 — GETTIG STYRL-JECT DELIVERY SYSTEM (September 11, 1997)

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