Plain Surgical Mask

Mask, Surgical

AOK Tooling Limited

The following data is part of a premarket notification filed by Aok Tooling Limited with the FDA for Plain Surgical Mask.

Pre-market Notification Details

Device IDK201517
510k NumberK201517
Device Name:Plain Surgical Mask
ClassificationMask, Surgical
Applicant AOK Tooling Limited #8, Longtian 3Rd, Longtian Street, Pingshan Dist. Shenzhen,  CN 518122
ContactFrancis Nithyananthan
CorrespondentPaul Dryden
AOK Tooling Limited% ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg,  FL  33704
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-08
Decision Date2020-09-04

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