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510(k) K213457

Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 by Fort Defiance Industries, LLC — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2022
Date Received
October 27, 2021
Clearance Type
Abbreviated
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

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  • K250164 — Cassette Autoclave (ACA5) (August 14, 2025)
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  • K243801 — FRONT-LINE Field Sterilizer (FL135) (March 7, 2025)
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  • K233504 — Lexa MINI (RIS-303, RIS-305) (February 8, 2024)
  • K233132 — PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (December 19, 2023)
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