SPUNGUARD FACE MASK

Mask, Surgical

KIMBERLY-CLARK CORP.

The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Spunguard Face Mask.

Pre-market Notification Details

Device IDK823078
510k NumberK823078
Device Name:SPUNGUARD FACE MASK
ClassificationMask, Surgical
Applicant KIMBERLY-CLARK CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-10-19
Decision Date1983-01-07

NIH GUDID Devices

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