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510(k) K231500

Vis-U-All Low Temperature Sterilization Pouches by STERIS Corporation — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2023
Date Received
May 24, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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