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510(k) K153674

Sorbact Foam Gentle Border, Sorbact Superabsorbent by Abigo Medical AB — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2016
Date Received
December 21, 2015
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

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  • K920840 — OTOVENT (October 5, 1992)

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