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510(k) K840021

OPERATING ROOM TRAY SET by Medi-Plast Intl., Inc. — Product Code FSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1984
Date Received
January 5, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Medi-Plast Intl., Inc.

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  • K863402 — MEDI-PLAST DISPOSABLE MANIFOLD (October 22, 1986)
  • K861785 — FLUOROSCOPE BAND BAG (June 13, 1986)
  • K851489 — ARTERIAL-VENOUS COMPRESSION DRESSING (June 11, 1985)
  • K842136 — STERILE PAN SET (July 6, 1984)
  • K840022 — HEART CATHETERIZATION TRAY SET (February 4, 1984)
  • K811234 — I.V. BOTTLE (RIDGID) (June 18, 1981)
  • K811268 — BOTTLE-TO-BOTTLE (June 18, 1981)
  • K811233 — I.V. PLASTIC BAG (June 17, 1981)

Other clearances for product code FSM

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  • K962328 — SINGLE USE INSTRUMENT TRAY (August 9, 1996)
  • K944025 — SURGICAL INSTRUMENT TRAY (November 22, 1994)
  • K912106 — ARTHROSCOPY TRAY (August 29, 1991)
  • K912053 — OPEN HEART TRAY (August 26, 1991)
  • K912052 — HEART CATH TRAY (August 20, 1991)
  • K912104 — MAJOR BASIN TRAY (August 9, 1991)
  • K910570 — SPLINTER TWEEZERS (May 31, 1991)
  • K911601 — REDDICK TROCAR AND CANNULA (May 21, 1991)
  • K910328 — KEY COMFORT GRIPS (March 6, 1991)