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510(k) K181865

Acu-sInQ Complete Endoscope Cleaning Aid System by STERIS Corporation — Product Code FEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2018
Date Received
July 12, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Cleaning, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
HO
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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