Monoject Sterile 3cc Syringes W/ & Wo/ Needles

• • Terminated Z-0051-2007 FDA Unclassified (pre-2012) ·initiated 11 Sep 2006

  Incorrect needle: There is an incorrect needle configuration on the syringe. The correct needle has a 27 gage A-bevel, the needle on the syringe has no bevel, typically used for dental irrigation.

510(k) Number

K852544 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Argyle Vac-U-Care 100cc Suct. Reservoir

  Class I

  FDA 510(k) K801372 Active Cleared 26 Jun 1980

• Argyle Aspr-Care Closed Suction System

  Class I

  FDA 510(k) K934723 Active Cleared 30 Nov 1993

• Labcer Fibrinogen Assay Kit & Calibr.

  Class II

  FDA 510(k) K812570 Active Cleared 2 Oct 1981

• Monoject(R) Trace Element Blood Collection Tube

  Class II

  FDA 510(k) K883320 Active Cleared 27 Sep 1988

• Monoject Samplette Amber Capillary Serum Separator

  Class I

  FDA 510(k) K875061 Active Cleared 12 Jan 1988

• Argyle Turkel Safety Trocar Thoracic Catheter

  Class I

  FDA 510(k) K933510 Active Cleared 24 Feb 1994

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