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510(k) K100029

MEPILEX BORDER AG DRESSING by Molnlycke Health Care — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2010
Date Received
January 6, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Molnlycke Health Care

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  • K122132 — AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LA (January 17, 2013)
  • K102923 — BARRIER N95 PARTICULATE RESPIRATOR (November 19, 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)
  • K031131 — KLINIDRAPE SURGICAL DRAPES (June 10, 2003)

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