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510(k) K143151

Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) by Bsn Medical GmbH — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2015
Date Received
November 3, 2014
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 Bsn Medical GmbH

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  • K123561 — ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS (December 18, 2012)

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