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510(k) K243801

FRONT-LINE Field Sterilizer (FL135) by Fort Defiance Industries, LLC — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2025
Date Received
December 11, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

Other clearances by Fort Defiance Industries, LLC

  • K213457 — Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Indust (March 2, 2022)
  • K141009 — FORT DEFIANCE AUTOMATED STEAM STERILIZER (December 16, 2014)

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