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510(k) K902828

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

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

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  • K943831 — PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943836 — PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943829 — PRE-FILLED SYSRINGE W/STERILE WATER (November 21, 1994)
  • K943828 — STERILE WATER FOR IRRIGATION (November 21, 1994)
  • K943833 — STERILE WATER FOR IRRATION (November 1, 1994)
  • K923168 — DUAL PORT ENTERAL Y-ADAPTOR (June 17, 1994)

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  • K892823 — PLASTER CUTTING SCISSORS (May 25, 1989)
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  • K891889 — OLIVECORONA SCISSORS (April 12, 1989)
  • K891203 — SCISSORS: THOREK, JORGENSEN, FINOCHIETTO (April 6, 1989)
  • K891200 — RIBBON TYPE SCISSORS: TENOTOMY,IRIS,EYE,STRABISMUS (April 6, 1989)
  • K890235 — DRESSING SCISSORS (February 3, 1989)
  • K890170 — SCISSORS (February 3, 1989)