510(k) K912117

LACERATION TRAY by Medical Device Inspection Co., Inc. — Product Code MCY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 9, 1991
Date Received: May 13, 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 Medical Device Inspection Co., Inc.

K945826 — J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFT (August 4, 1995)
K932072 — JARIT SURGICAL INSTRUMENTS (January 11, 1994)
K931594 — THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM (December 21, 1993)
K933581 — POWERMATIC TREATMENT TABLE (November 5, 1993)
K933580 — POWER WORK TABLE (November 5, 1993)
K933578 — POWERMATIC MAT PLATFORM (November 5, 1993)
K933577 — POWERMATIC EXAMINATION TABLE (September 30, 1993)
K922045 — SHOWER CHAIRS (May 26, 1992)
K912075 — C-SECTION TRAY (April 7, 1992)
K914174 — STERILE DISPOSABLE WET SKIN SCRUB TRAY (February 24, 1992)

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)