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510(k) K153392

STERIZONE VP4 Sterilizer by Ts03, Inc. — Product Code PJJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 24, 2016
Date Received: November 24, 2015
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Two Or More Sterilant Sterilizer
Device Class: Class II
Regulation Number: 880.6860
Review Panel: HO
Submission Type

Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.