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510(k) K902828

SUTURE REMOVAL TRAY by Orion Life Systems, Inc. — Product Code LRW

K902828 is an FDA 510(k) premarket notification submitted by Orion Life Systems, Inc. for the device "SUTURE REMOVAL TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on August 8, 1990. The device falls under product code LRW (Scissors, General, Surgical), a Class I device regulated under 21 CFR 878.4800. Orion Life Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
August 8, 1990
Date Received
June 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scissors, General, Surgical
Device Class
Class I
Regulation Number
878.4800
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 LRW

  • K911158 — MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM (March 29, 1991)
  • K900957 — GS-2100 HOOK SUTURE SCISSOR, 5MM (April 18, 1990)
  • K900950 — GS-2000 MICRO SCISSOR, CURVED LEFT, 5MM (April 18, 1990)
  • K892823 — PLASTER CUTTING SCISSORS (May 25, 1989)
  • K891889 — OLIVECORONA SCISSORS (April 12, 1989)
  • K891886 — SCISSORS, VARIOUS TYPES (April 12, 1989)
  • K891200 — RIBBON TYPE SCISSORS: TENOTOMY,IRIS,EYE,STRABISMUS (April 6, 1989)
  • K891203 — SCISSORS: THOREK, JORGENSEN, FINOCHIETTO (April 6, 1989)
  • K890170 — SCISSORS (February 3, 1989)
  • K890235 — DRESSING SCISSORS (February 3, 1989)

FDA data resources