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510(k) K832137

CONVERTORS FLASH STERILIZING TRAY by American Convertors Div., American Pharmaseal — Product Code FSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
July 1, 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 American Convertors Div., American Pharmaseal

  • K840957 — ANTIMICROBIAL INCISE DRAPE (June 7, 1984)
  • K830786 — DISIMETRIC RELEASE OF INSTRANETICS RAD (May 18, 1983)
  • K820994 — ABSORB FURN SHEET (May 13, 1982)
  • K813419 — COMFORT CUSHION DRY BURN PAD III (January 22, 1982)
  • K813296 — CONVERTORS STERILE DISP. LAP SPONGE II (December 29, 1981)
  • K813078 — CONTURA DISPOS. SURG. FACE MASK (December 18, 1981)
  • K812554 — TOMAC STERILE DISP. LAP SPONGE (September 24, 1981)
  • K802919 — ISO-BAC INSTRUMENT WRAP (February 2, 1981)
  • K802998 — PATIENT CARE DISPOSABLE INFANT SHIRTS (December 22, 1980)
  • K802359 — DISP. FENESTRATED SURG. DRAPE SHEETS (October 31, 1980)

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)