510(k) K142454

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer by Advanced Sterilization Products — Product Code MLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2015
Date Received
September 2, 2014
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