CareGUARD Sterilization Wrap

Wrap, Sterilization

Care Essentials Pty Ltd

The following data is part of a premarket notification filed by Care Essentials Pty Ltd with the FDA for Careguard Sterilization Wrap.

Pre-market Notification Details

• Device ID: K213907
• 510k Number: K213907
• Device Name: CareGUARD Sterilization Wrap
• Classification: Wrap, Sterilization
• Applicant: Care Essentials Pty Ltd 103 Mornington Street North Geelong, AU 3215
• Contact: Abhay Sinha
• Correspondent: Abhay Sinha; Care Essentials Pty Ltd 103 Mornington Street North Geelong, AU 3215
• Product Code: FRG
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-12-14
• Decision Date: 2022-03-14

NIH GUDID Devices

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