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510(k) K952334

DRESSING CHANGE TRAY by Busse Hospital Disposables, Inc. — Product Code MCY

K952334 is an FDA 510(k) premarket notification submitted by Busse Hospital Disposables, Inc. for the device "DRESSING CHANGE TRAY". The FDA issued a decision of Substantially Equivalent on July 14, 1995. The device falls under product code MCY (Wound Dressing Kit), a Class II device regulated under 21 CFR 880.5075. Busse Hospital Disposables, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1995
Date Received
May 18, 1995
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 Busse Hospital Disposables, Inc.

  • K141285 — BUSSE EXTENSION SET (February 19, 2015)
  • K120002 — I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE (June 26, 2012)
  • K110883 — J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION (June 8, 2011)
  • K093920 — BUSSE EPIDURAL CATHETER KIT (August 6, 2010)
  • K093909 — BUSSE SURGICAL DRAPES IV (May 6, 2010)
  • K092212 — BUSSE SURGICAL DRAPES III (October 9, 2009)
  • K082297 — BUSSE SURGICAL DRAPE (December 9, 2008)
  • K073222 — MODIFICATION TO:SPECIALTY NEEDLES (April 9, 2008)
  • K070465 — BUSSE EPIDURAL CATHETER (July 19, 2007)
  • K063018 — GLASS LOSS OF RESISTANCE SYRINGE (January 22, 2007)

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)
  • 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)
  • K924690 — VARIOUS NON-STERILE CUSTOM TRAYS/KITS (July 16, 1993)
  • K923905 — WOUND DRESSING KIT (July 2, 1993)
  • K925021 — TPN TRAY (STERILE) (June 7, 1993)

FDA data resources