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510(k) K182404

STERRAD VELOCITY Biological Indicator by Advanced Sterilization Products (Asp) — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2018
Date Received
September 4, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

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