510(k) K921347

CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER by Medi-Flex Hospital Products, Inc. — Product Code MCY

Clearance Details

Decision: SEKD (Substantially Equivalent (kit, denovo))
Decision Date: January 8, 1993
Date Received: March 18, 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 by Medi-Flex Hospital Products, Inc.

K970441 — K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH (May 9, 1997)
K962740 — DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641 (September 6, 1996)
K952201 — PORT-A-CATH ACCESS KIT (October 4, 1995)
K952416 — TRACHEOSTOMY CARE KIT (August 9, 1995)
K952256 — PICC LINE KIT (July 31, 1995)
K952007 — ADHEROL SEPP APPLICATOR (June 8, 1995)
K934790 — SEPP ADHESIVE REMOVER (March 11, 1994)
K923516 — COMPOUND BENZOIN TINCTURE USP SEPP (January 25, 1994)
K920399 — COMPOUND BENZOIN TINCTURE USP FREPP (January 25, 1994)
K930196 — CEPTI-SEAL I.V. PREP KIT (July 2, 1993)

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)
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)