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510(k) K984371

MEPITEL NON ADHERENT SILICONE DRESSING by Molnlycke Health Care, Inc. — Product Code MGP

K984371 is an FDA 510(k) premarket notification submitted by Molnlycke Health Care, Inc. for the device "MEPITEL NON ADHERENT SILICONE DRESSING". The FDA issued a decision of Substantially Equivalent on March 3, 1999. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Molnlycke Health Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1999
Date Received
December 7, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Occlusive
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Molnlycke Health Care, Inc.

  • K130852 — AVANCE® FOAM ABDOMINAL DRESSING KIT (April 14, 2014)
  • K130040 — MEPITEL AG (February 12, 2014)
  • K123892 — MEPILEX TRANSFER AG (April 5, 2013)
  • K122132 — AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LA (January 17, 2013)
  • K102923 — BARRIER N95 PARTICULATE RESPIRATOR (November 19, 2010)
  • K100029 — MEPILEX BORDER AG DRESSING (September 15, 2010)
  • K061554 — MEPILEX AG ABSORBENT SILICONE-COATED DRESSING (January 25, 2007)
  • K062138 — POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPREN (October 5, 2006)
  • K051625 — BARRIER SURGICAL DRAPES (July 14, 2005)
  • K050786 — BARRIER SURGICAL GOWNS (May 9, 2005)

Other clearances for product code MGP

  • K012995 — COLLATEK SHEET (October 25, 2001)
  • K012997 — COLLATEK FOAM (October 25, 2001)
  • K001508 — LASERSKIN DRESSING (July 25, 2001)
  • K990079 — FASTSEAL CHEST WOUND DRESSING (December 23, 1999)
  • K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING (October 14, 1999)
  • K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (September 14, 1999)
  • K992005 — GILTECH PLUS TRANSPARENT DRESSING (September 3, 1999)
  • K990875 — DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (May 27, 1999)
  • K990438 — DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSI (March 25, 1999)
  • K983303 — INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSING (December 9, 1998)

FDA data resources