Cardinal Health™ Level 3 Surgical Mask With Anti-Fog Foam Strip

Mask, Surgical

Cardinal Health 200, LLC

The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Cardinal Health™ Level 3 Surgical Mask With Anti-fog Foam Strip.

Pre-market Notification Details

• Device ID: K192374
• 510k Number: K192374
• Device Name: Cardinal Health™ Level 3 Surgical Mask With Anti-Fog Foam Strip
• Classification: Mask, Surgical
• Applicant: Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan, IL 60085
• Contact: Dominic Tunzi
• Correspondent: Dominic Tunzi; Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan, IL 60085
• Product Code: FXX
• CFR Regulation Number: 878.4040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-30
• Decision Date: 2019-12-02