Home / 510(k) Clearances / K823855

510(k) K823855

MEDCARE INCISION & DRAINAGE TRAY by Medcare Products — Product Code FSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1983
Date Received
December 22, 1982
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 Medcare Products

  • K841122 — TRACHEOSTOMY CARE TRAY (April 25, 1984)
  • K841124 — DIALYSIS TRAY (April 20, 1984)
  • K841123 — DRESSING CHANGE TRAY (April 17, 1984)
  • K831374 — MED CARE PREP RAZOR (October 4, 1983)
  • K831663 — TISSUE FORCEPS (September 26, 1983)
  • K831664 — PLASTIC THUMB FORCEPS (September 12, 1983)
  • K831665 — DISPOSABLE NEEDLE HOLDER (September 12, 1983)
  • K831661 — DISPOSABLE SCISSORS (August 25, 1983)
  • K831662 — DISPOSABLE HEMOSTAT (STRAIGHT&CURVED (July 19, 1983)
  • K823854 — MEDCARE SUTURE REMOVAL TRAYS (March 31, 1983)

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)