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510(k) K924690

VARIOUS NON-STERILE CUSTOM TRAYS/KITS by Surgipro Central, Inc. — Product Code MCY

K924690 is an FDA 510(k) premarket notification submitted by Surgipro Central, Inc. for the device "VARIOUS NON-STERILE CUSTOM TRAYS/KITS". The FDA issued a decision of Substantially Equivalent (kit, denovo) on July 16, 1993. The device falls under product code MCY (Wound Dressing Kit), a Class II device regulated under 21 CFR 880.5075.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
July 16, 1993
Date Received
September 17, 1992
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 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)
  • K951022 — CIRCULON SYSTEM STEP 1 (June 12, 1995)
  • K951021 — CIRCULON SYSTEM STEP 2 (June 12, 1995)
  • K951476 — E-PACK PROCEDURE KITS (May 23, 1995)
  • K931932 — DRESSING CHANGE TRAY-MODIFIED (August 27, 1993)
  • K923905 — WOUND DRESSING KIT (July 2, 1993)
  • K925021 — TPN TRAY (STERILE) (June 7, 1993)

FDA data resources