AOK 95A Medical Mask (20200049)

Mask, Surgical

AOK Tooling Limited

The following data is part of a premarket notification filed by Aok Tooling Limited with the FDA for Aok 95a Medical Mask (20200049).

Pre-market Notification Details

Device IDK220876
510k NumberK220876
Device Name:AOK 95A Medical Mask (20200049)
ClassificationMask, Surgical
Applicant AOK Tooling Limited Flat 2009, 20/F, Kowloon Plaza, No.485, Castle Peak Road Cheung Sha Wan, Kowloon,  CN 518122
ContactFrancis Nithyananthan
CorrespondentPaul Dryden
AOK Tooling Limited C/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg,  FL  33704
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-25
Decision Date2022-07-27

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