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510(k) K811916

OPERATING ROOM KIT by American Hospital Supply Corp. — Product Code FSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1981
Date Received
July 1, 1981
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

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  • K830546 — DOSIMETRIC RELEASE (May 25, 1983)
  • K822990 — CONVERTORS PRIMARY WOUND DRESSING II (April 12, 1983)
  • K830343 — CONTAINER W/PRIMING SOLUTION (March 17, 1983)
  • K830301 — STRATUS FLUOROMETRIC ENZYME IMMUN0- (February 25, 1983)
  • K822755 — LATEX PENROSE TUBING (January 21, 1983)
  • K823418 — HEYER-SCHUTE UNIVERSAL URETERAL STENT (December 3, 1982)
  • K822966 — CONVERTORS DISPOSABLE DRESSING SPONGE (November 5, 1982)

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  • 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)