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510(k) K160903

STERRAD 100NX Sterilizer with ALLClearTM Technology by Advanced Sterilization Products — Product Code MLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2016
Date Received
April 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Chemical
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

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