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510(k) K000455

GETTIG GUARD by Gettig Pharmaceutical Instrument Co. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2000
Date Received
February 11, 2000
Clearance Type
Traditional
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

Other clearances by Gettig Pharmaceutical Instrument Co.

  • K041232 — GETTIG UNIVERSAL VIAL ACCESS PIN (July 22, 2004)
  • K033409 — AMERSHAM HEALTH NEEDLE-GUARD (January 21, 2004)
  • K022495 — GETTIG DISPOSABLE SYRINGES (October 8, 2002)
  • K972285 — GETTIG STYRL-JECT DELIVERY SYSTEM (September 11, 1997)

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  • K240355 — FROG (Filter Removal of Glass) (April 18, 2025)
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