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510(k) K200767

SilverStream Gel by Enzysurge , Ltd. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2020
Date Received
March 25, 2020
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 Enzysurge , Ltd.

  • K093227 — SILVERSTREAM AND DERMASEPT (December 10, 2009)
  • K060046 — DERMASTREAM (February 27, 2006)

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