Surgical Mask - Level 3 - Blue - 50 Pcs, Surgical Mask - Level 3 - White - 50 Pcs, Procedure Mask - Level 3 - Blue - 50 Pcs, Procedure Mask - Level 3 - White - 50 Pcs

Mask, Surgical

String King Lacrosse, LLC

The following data is part of a premarket notification filed by String King Lacrosse, Llc with the FDA for Surgical Mask - Level 3 - Blue - 50 Pcs, Surgical Mask - Level 3 - White - 50 Pcs, Procedure Mask - Level 3 - Blue - 50 Pcs, Procedure Mask - Level 3 - White - 50 Pcs.

Pre-market Notification Details

Device IDK202607
510k NumberK202607
Device Name:Surgical Mask - Level 3 - Blue - 50 Pcs, Surgical Mask - Level 3 - White - 50 Pcs, Procedure Mask - Level 3 - Blue - 50 Pcs, Procedure Mask - Level 3 - White - 50 Pcs
ClassificationMask, Surgical
Applicant String King Lacrosse, LLC 19100 S Vermont Ave. Gardena,  CA  90248
ContactThomas Frasca
CorrespondentRobert V. Packard
Medical Device Academy Inc. 345 Lincoln Hill Road Shrewsbury,  VT  05738
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-09
Decision Date2021-04-23

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