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510(k) K931932

DRESSING CHANGE TRAY-MODIFIED by Medsurg Industries, Inc. — Product Code MCY

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
August 27, 1993
Date Received
April 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing Kit
Device Class
Class II
Regulation Number
880.5075
Review Panel
SU
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Medsurg Industries, Inc.

  • K920780 — MEDSURG INSERTION TRAY (August 19, 1994)
  • K940175 — MEDSURG STERILE O.R. TOWELS (May 26, 1994)
  • K934731 — MEDSURG STERILE IMAGING PRODUCTS (March 28, 1994)
  • K925558 — INFILTUBE (March 4, 1994)
  • K934971 — STERILE LAPAROTOMY SPONGES (February 7, 1994)
  • K920421 — MEDSURG MARSHMALLOW TRAY (December 13, 1993)
  • K920838 — MEDSURG CIRCUMCISION TRAY (October 15, 1993)
  • K914037 — MEDSURG O.R. PROCEDURE TRAY (June 22, 1993)
  • K914036 — MEDSURG LAPAROSCOPY TRAY (March 18, 1992)
  • K893938 — CONTINUOUS EPIDURAL ANESTHESIA TRAY (August 7, 1989)

Other clearances for product code MCY

  • K970721 — DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM (March 21, 1997)
  • K963719 — CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY (November 27, 1996)
  • K960585 — WOUND CARE COMPRESSION SYSTEM (WCCS) (April 26, 1996)
  • K952334 — DRESSING CHANGE TRAY (July 14, 1995)
  • K951021 — CIRCULON SYSTEM STEP 2 (June 12, 1995)
  • K951022 — CIRCULON SYSTEM STEP 1 (June 12, 1995)
  • K951476 — E-PACK PROCEDURE KITS (May 23, 1995)
  • K924690 — VARIOUS NON-STERILE CUSTOM TRAYS/KITS (July 16, 1993)
  • K923905 — WOUND DRESSING KIT (July 2, 1993)
  • K925021 — TPN TRAY (STERILE) (June 7, 1993)