SAFE SECURE STERILIZATION POUNCH 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 Pounch With Steam And Ethylene Oxide Process Indicators.

Pre-market Notification Details

• Device ID: K112591
• 510k Number: K112591
• Device Name: SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS
• Classification: Wrap, Sterilization
• Applicant: SAFE SECURE PACKAGING CO., LTD CHENGGUANG INDUSTRIAL PARK, NO.4 KUKENG PO NEW VILLAGE Shenzhen, Guangdon, CN 5181100
• Contact: Garfield Wang
• Correspondent: Paula Wilkerson; INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087
• Product Code: FRG
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2011-09-07
• Decision Date: 2012-02-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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