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510(k) K902811

ROUTINE DRESSING TRAY by Orion Life Systems, Inc. — Product Code MCY

K902811 is an FDA 510(k) premarket notification submitted by Orion Life Systems, Inc. for the device "ROUTINE DRESSING TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on September 25, 1990. The device falls under product code MCY (Wound Dressing Kit), a Class II device regulated under 21 CFR 880.5075. Orion Life Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
September 25, 1990
Date Received
June 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing Kit
Device Class
Class II
Regulation Number
880.5075
Review Panel
SU
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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)
  • K943829 — PRE-FILLED SYSRINGE W/STERILE WATER (November 21, 1994)
  • K943832 — STERILE .9% SODIUM CHLORIDE FOR IRRATION (November 21, 1994)
  • K943831 — PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943836 — PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943828 — STERILE WATER FOR IRRIGATION (November 21, 1994)
  • K943830 — PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION (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 MCY

  • K970721 — DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM (March 21, 1997)
  • K963719 — CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY (November 27, 1996)
  • K960585 — WOUND CARE COMPRESSION SYSTEM (WCCS) (April 26, 1996)
  • K952334 — DRESSING CHANGE TRAY (July 14, 1995)
  • K951022 — CIRCULON SYSTEM STEP 1 (June 12, 1995)
  • K951021 — CIRCULON SYSTEM STEP 2 (June 12, 1995)
  • K951476 — E-PACK PROCEDURE KITS (May 23, 1995)
  • K931932 — DRESSING CHANGE TRAY-MODIFIED (August 27, 1993)
  • K924690 — VARIOUS NON-STERILE CUSTOM TRAYS/KITS (July 16, 1993)
  • K923905 — WOUND DRESSING KIT (July 2, 1993)

FDA data resources