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510(k) K890473

NEEDLE GUARD(TM) by Martech Medical Products, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1989
Date Received
January 31, 1989
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

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  • K960519 — MARTECH ENDOSCOPIC INJECTION NEEDLE (May 1, 1996)
  • K931924 — MARKSMAN ARTERIAL BLOOD GAS SYRINGE (August 3, 1993)
  • K922438 — PRO2 OXYGEN ANALYZER (March 5, 1993)
  • K926007 — ACCESSORY TO PISTON SYRINGE (February 23, 1993)
  • K914778 — NEOLINE(TM) (September 16, 1992)
  • K910970 — MARKSMAN ARTERIAL BLOOD GAS SYRINGE (October 15, 1991)

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