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510(k) K092257

JALOSKIN by Fidia Advanced Biopolymers Srl — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2010
Date Received
July 28, 2009
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 Fidia Advanced Biopolymers Srl

  • K073251 — HYALOMATRIX PA (December 14, 2007)
  • K001508 — LASERSKIN DRESSING (July 25, 2001)
  • K003855 — HYALOMATRIX CO (July 3, 2001)

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