510(k) K912232

ULCERCARE by Jobst Institute, Inc. — Product Code MCY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 14, 1991
Date Received: May 20, 1991
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 Jobst Institute, Inc.

K955138 — ANTI-EM/GP STOCKINGS (December 13, 1995)
K953763 — GLADIATOR ANTISHOCK PANTS (November 28, 1995)
K925154 — JOBST-CUSTOM (April 4, 1994)
K925583 — JOBSKIN CONTINUING CARE (April 4, 1994)
K934639 — JOBST ATHROMBIC PUMP - SYSTEM 2500 (February 9, 1994)
K922681 — CUTINOVA FOAM (August 31, 1992)
K921562 — JOBST EXTREMITY PUMP SYSTEM 7500 (June 22, 1992)
K920444 — ULTIMATE (April 20, 1992)
K911247 — YOURS TRULY ASYMMETRICAL BREAST FORM (March 29, 1991)
K905631 — COMPRINET, COMTESSE AND BELLAVAR STOCKINGS (March 7, 1991)

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)