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510(k) K900736

BULB IRRIGATION TRAY by Orion Life Systems, Inc. — Product Code EYN

K900736 is an FDA 510(k) premarket notification submitted by Orion Life Systems, Inc. for the device "BULB IRRIGATION TRAY". The FDA issued a decision of Substantially Equivalent (kit) on April 17, 1990. The device falls under product code EYN (Tray, Irrigation, Sterile), a Class II device regulated under 21 CFR 876.5980. Orion Life Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 17, 1990
Date Received
February 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Irrigation, Sterile
Device Class
Class II
Regulation Number
876.5980
Review Panel
SU
Submission Type

Other clearances by Orion Life Systems, Inc.

  • K943835 — PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID (January 24, 1995)
  • K943834 — STERILE .9% SODIUM CHLORIDE SOLUTION (November 21, 1994)
  • K943836 — PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943831 — PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943830 — PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION (November 21, 1994)
  • K943829 — PRE-FILLED SYSRINGE W/STERILE WATER (November 21, 1994)
  • K943828 — STERILE WATER FOR IRRIGATION (November 21, 1994)
  • K943832 — STERILE .9% SODIUM CHLORIDE FOR IRRATION (November 21, 1994)
  • K943833 — STERILE WATER FOR IRRATION (November 1, 1994)
  • K923168 — DUAL PORT ENTERAL Y-ADAPTOR (June 17, 1994)

Other clearances for product code EYN

  • K944882 — IRRIGATION TRAY (January 12, 1995)
  • K923941 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE (June 17, 1993)
  • K923938 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER (June 17, 1993)
  • K923939 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER (June 17, 1993)
  • K923940 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE (June 17, 1993)
  • K900148 — KIT PAK IRRIGATION TRAY (April 23, 1990)
  • K900737 — PISTON IRRIGATION TRAY (April 19, 1990)
  • K801783 — CATHETER IRRIGATION TRAYS, #3300, 3310 & (August 13, 1980)
  • K792082 — GAVAGE FEEDING SET (November 13, 1979)
  • K791020 — FLUID ADMINISTRATION SET FA-3160 (June 27, 1979)

FDA data resources