SYSTEM 1.5 STERILE PROCESSING SYSTEM

Sterilant, Medical Devices

STERIS Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for System 1.5 Sterile Processing System.

Pre-market Notification Details

• Device ID: K090036
• 510k Number: K090036
• Device Name: SYSTEM 1.5 STERILE PROCESSING SYSTEM
• Classification: Sterilant, Medical Devices
• Applicant: STERIS Corporation 5960 Heisley Road Mentor, OH 44060
• Contact: Peter Burke
• Correspondent: Peter Burke; STERIS Corporation 5960 Heisley Road Mentor, OH 44060
• Product Code: MED
• CFR Regulation Number: 880.6885 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-01-06
• Decision Date: 2010-04-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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