VERIFY® HPU Chemical Indicator And VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label

Indicator, Physical/chemical Sterilization Process

STERIS Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify® Hpu Chemical Indicator And Verify® Vaporized Vh2o2 Process Indicator Adhesive Label.

Pre-market Notification Details

• Device ID: K172746
• 510k Number: K172746
• Device Name: VERIFY® HPU Chemical Indicator And VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
• Classification: Indicator, Physical/chemical Sterilization Process
• Applicant: STERIS Corporation 5960 Heisley Road Mentor, OH 44060
• Contact: Bill Brodbeck
• Correspondent: Bill Brodbeck; STERIS Corporation 5960 Heisley Road Mentor, OH 44060
• Product Code: JOJ
• CFR Regulation Number: 880.2800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-12
• Decision Date: 2018-02-09
• Summary: summary