V-PRO® 1 Plus And V-PRO® MaX Low Temperature

Sterilizer, Chemical

STERIS CORPORATION

The following data is part of a premarket notification filed by Steris Corporation with the FDA for V-pro® 1 Plus And V-pro® Max Low Temperature.

Pre-market Notification Details

• Device ID: K160433
• 510k Number: K160433
• Device Name: V-PRO® 1 Plus And V-PRO® MaX Low Temperature
• Classification: Sterilizer, Chemical
• 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: MLR
• CFR Regulation Number: 880.6860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-16
• Decision Date: 2016-07-06
• Summary: summary