EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR

Accessories, Cleaning, For Endoscope

ADVANCED STERILIZATION PRODUCTS

The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Evotech Endoscope Cleaner And Reprocessor.

Pre-market Notification Details

• Device ID: K082392
• 510k Number: K082392
• Device Name: EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR
• Classification: Accessories, Cleaning, For Endoscope
• Applicant: ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618
• Contact: Joseph Ascenzi, Ph.d.
• Correspondent: Joseph Ascenzi, Ph.d.; ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618
• Product Code: FEB
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-08-19
• Decision Date: 2008-11-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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