Spin Care Disposable Protective Mask

Mask, Surgical

SpinTech LLC

The following data is part of a premarket notification filed by Spintech Llc with the FDA for Spin Care Disposable Protective Mask.

Pre-market Notification Details

Device IDK201624
510k NumberK201624
Device Name:Spin Care Disposable Protective Mask
ClassificationMask, Surgical
Applicant SpinTech LLC 1920 Flintstone Drive Statesville,  NC  28677
ContactJim Jean
CorrespondentW. Victoria Rogers
Rogers Consulting 11110 Arranmore Cove Roanoke,  IN  46783
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-15
Decision Date2021-03-18

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