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510(k) K912116

PRESSURE SORE MANAGEMENT KIT by Medical Device Inspection Co., Inc. — Product Code MCY

K912116 is an FDA 510(k) premarket notification submitted by Medical Device Inspection Co., Inc. for the device "PRESSURE SORE MANAGEMENT KIT". The FDA issued a decision of Substantially Equivalent on October 18, 1991. The device falls under product code MCY (Wound Dressing Kit), a Class II device regulated under 21 CFR 880.5075. Medical Device Inspection Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1991
Date Received
May 14, 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)
  • K933578 — POWERMATIC MAT PLATFORM (November 5, 1993)
  • K933580 — POWER WORK TABLE (November 5, 1993)
  • K933581 — POWERMATIC TREATMENT TABLE (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)
  • 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)

FDA data resources