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510(k) K830219

VARIOUS INSTRUMENTS & INSTRUMENT TRAYS by Ascep, Inc. — Product Code FSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1983
Date Received
January 24, 1983
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 Ascep, Inc.

  • K822893 — G.E.V. DISPOSABLE SCALPELS (October 22, 1982)
  • K810004 — STERILE DISPOSABLE INSTRUMENT TRAYS (January 26, 1981)
  • K802726 — INSTRUMENTS NONSTERILE & STERILE (November 19, 1980)
  • K791886 — I.V. CARE KIT (October 26, 1979)
  • K791885 — I.V. START SET (October 22, 1979)
  • K791888 — CATHETER CARE KIT REORDER 7940&7941 (October 17, 1979)
  • K791889 — SUTURE REMOVAL TRAY, REORDER 7950&7951 (October 17, 1979)
  • K791887 — CENTRAL VENOUS CATHETER DRESSING TRAY (October 17, 1979)

Other clearances for product code FSM

  • K971217 — INSTRUMENT TRAY LINER (May 6, 1997)
  • 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)