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510(k) K171225

Sorbact Wound Dressing-Ribbon Gauze by Abigo Medical AB — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2017
Date Received
April 26, 2017
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 Abigo Medical AB

  • K153674 — Sorbact Foam Gentle Border, Sorbact Superabsorbent (July 1, 2016)
  • K100591 — SORBACT (January 24, 2011)
  • K063059 — SORBACT WOUND DRESSING (April 19, 2007)
  • K920840 — OTOVENT (October 5, 1992)

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