SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500) +2 more— 510(k) K232914

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K232914 for SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500) +2 more, Substantially Equivalent on 2023-10-03. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Device name as filed
SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)
Applicant
STERIS Corporation
Product code
Code MED
Device class
Class 2
Regulation
21 CFR 880.6885
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mentor, OH, US
Download summary PDFView on FDA.gov ↗

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