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510(k) K240552

Irrisept Antimicrobial Wound Lavage by Irrimax Corporation — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2024
Date Received
February 28, 2024
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 Irrimax Corporation

  • K222804 — Irrisept Antimicrobial Wound Lavage (September 22, 2022)
  • K210536 — Irrisept Antimicrobial Wound Lavage (May 28, 2021)
  • K202222 — Irrisept Wound Debridement and Cleansing System (December 14, 2020)
  • K080779 — IRRISEPT WOUND CLEANSING SYSTEM (February 4, 2009)

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