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 IDK210513
510k NumberK210513
Device Name:UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2
ClassificationMask, Surgical
Applicant Universal Incorporation 10F., No.372 Linsen N. Rd.,Zhongshan Dist. Taipei City,  TW 10446
ContactMei-hui Huang
CorrespondentTyra Chiu
VOLER Biotech Consulting Co., Ltd. 1 Ft, No 3-1, Ln. 58, Hejiang St., Zhongshan Dist. Taipei,  TW 72548
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-23
Decision Date2021-09-29

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