510(k) Premarket Notification

• Device Classification Name: sterilizer, chemical
• 510(K) Number: K030429
• Device Name: STERRAD 200 STERILIZER
• Applicant: ADVANCED STERILIZATION PRODUCTS; 33 technology dr.; irvine, CA 92618
• Contact: natalie bennington
• Regulation Number: 880.6860
• Classification Product Code: MLR
• Subsequent Product Code: FLF
• Date Received: 02/10/2003
• Decision Date: 08/18/2003
• 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