Tyvek® Pouch/Roll With STERRAD® Chemical Indicator

Wrap, Sterilization

ADVANCED STERILIZATION PRODUCTS

The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Tyvek® Pouch/roll With Sterrad® Chemical Indicator.

Pre-market Notification Details

• Device ID: K141693
• 510k Number: K141693
• Device Name: Tyvek® Pouch/Roll With STERRAD® Chemical Indicator
• Classification: Wrap, Sterilization
• Applicant: ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618
• Contact: Sun Choi
• Correspondent: Sun Choi; ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618
• Product Code: FRG
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-06-24
• Decision Date: 2014-12-19
• Summary: summary