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510(k) K971217

INSTRUMENT TRAY LINER by General Hospital Supply Corp. — Product Code FSM

K971217 is an FDA 510(k) premarket notification submitted by General Hospital Supply Corp. for the device "INSTRUMENT TRAY LINER". The FDA issued a decision of Substantially Equivalent on May 6, 1997. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1997
Date Received
April 2, 1997
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 for product code FSM

  • 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)
  • K905682 — RICHARD-ALLAN CLAMP COVERS (February 19, 1991)

FDA data resources