UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2

Mask, Surgical

Universal Incorporation

The following data is part of a premarket notification filed by Universal Incorporation with the FDA for Uniweb Surgical Mask, Model: Astm Level 1, Uniweb Surgical Mask, Model: Astm Level 2.

Pre-market Notification Details

• Device ID: K210513
• 510k Number: K210513
• Device Name: UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2
• Classification: Mask, Surgical
• Applicant: Universal Incorporation 10F., No.372 Linsen N. Rd.,Zhongshan Dist. Taipei City, TW 10446
• Contact: Mei-hui Huang
• Correspondent: Tyra Chiu; VOLER Biotech Consulting Co., Ltd. 1 Ft, No 3-1, Ln. 58, Hejiang St., Zhongshan Dist. Taipei, TW 72548
• Product Code: FXX
• CFR Regulation Number: 878.4040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-02-23
• Decision Date: 2021-09-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04715243610140	K210513	000