510(k) K952334

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

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)
K951021 — CIRCULON SYSTEM STEP 2 (June 12, 1995)
K951022 — CIRCULON SYSTEM STEP 1 (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)