510(k) Premarket Notification

• Device Classification Name: sterilizer, chemical
• 510(K) Number: K083097
• Device Name: AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM
• Applicant: STERIS CORPORATION; 5960 heisley road; mentor, OH 44060
• Contact: john r scoville
• Regulation Number: 880.6860
• Classification Product Code: MLR
• Date Received: 10/17/2008
• Decision Date: 08/03/2009
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: General Hospital
• Review Advisory Committee: General Hospital
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No