BioGuard Air/Water And Suction Valves

Endoscope Channel Accessory

STERIS Corporations

The following data is part of a premarket notification filed by Steris Corporations with the FDA for Bioguard Air/water And Suction Valves.

Pre-market Notification Details

Device IDK203630
510k NumberK203630
Device Name:BioGuard Air/Water And Suction Valves
ClassificationEndoscope Channel Accessory
Applicant STERIS Corporations 5976 Heisley Road Mentor,  OH  44060
ContactCarroll Martin
CorrespondentCarroll Martin
STERIS Corporations 5976 Heisley Road Mentor,  OH  44060
Product CodeODC  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-11
Decision Date2021-01-08

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