Banyan USA Surgical Mask Level 3

Mask, Surgical

Banyan USA LLC

The following data is part of a premarket notification filed by Banyan Usa Llc with the FDA for Banyan Usa Surgical Mask Level 3.

Pre-market Notification Details

Device IDK211097
510k NumberK211097
Device Name:Banyan USA Surgical Mask Level 3
ClassificationMask, Surgical
Applicant Banyan USA LLC 390 Oser Avenue Hauppauge,  NY  11788
ContactRicardo Ryan
CorrespondentTimothy Kania
MDI Consultants Inc. 55 Northern Blvd, Suite 200 Great Neck,  NY  11021
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-13
Decision Date2021-09-22

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