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510(k) K243181

Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo by Bionova Medical, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2024
Date Received
September 30, 2024
Clearance Type
Special
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 Bionova Medical, Inc.

  • K240298 — Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo (August 21, 2024)
  • K231937 — Foundation Dermal Regeneration Scaffold (DRS) Solo (November 13, 2023)
  • K210949 — Foundation Dermal Regeneration Scaffold (DRS) Solo (August 11, 2022)
  • K123961 — SENTREX BIOSPONGE MPD (April 5, 2013)
  • K112191 — HEALEX BIOSPONGE WOUND DRESSING (June 5, 2012)

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