Safe Secure Sterilization Pouch With Steam And Ethylene Oxide Process Indicators

Wrap, Sterilization

SAFE SECURE PACKAGING CO., LTD

The following data is part of a premarket notification filed by Safe Secure Packaging Co., Ltd with the FDA for Safe Secure Sterilization Pouch With Steam And Ethylene Oxide Process Indicators.

Pre-market Notification Details

• Device ID: K153540
• 510k Number: K153540
• Device Name: Safe Secure Sterilization Pouch With Steam And Ethylene Oxide Process Indicators
• Classification: Wrap, Sterilization
• Applicant: SAFE SECURE PACKAGING CO., LTD NO.4 CHENGGUANG INDUSTRIAL PARK GUNLAN STREET, BAOAN DISTRICT Shenzhen, CN 518100
• Contact: Howard Jia
• Correspondent: Brian Edwards; NAMSA 4050 OLSON MEMORIAL HIGHWAY Golden Valley, MN 55422
• Product Code: FRG
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-12-10
• Decision Date: 2016-08-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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