DEFEND FLUID RESISTANT PLEATED MASK

Mask, Surgical

CARL PARKER ASSOCIATES, INC.

The following data is part of a premarket notification filed by Carl Parker Associates, Inc. with the FDA for Defend Fluid Resistant Pleated Mask.

Pre-market Notification Details

Device IDK971130
510k NumberK971130
Device Name:DEFEND FLUID RESISTANT PLEATED MASK
ClassificationMask, Surgical
Applicant CARL PARKER ASSOCIATES, INC. 8309 BRYANT DR. Bethesda,  MD  20817
ContactNeal Dunning
CorrespondentNeal Dunning
CARL PARKER ASSOCIATES, INC. 8309 BRYANT DR. Bethesda,  MD  20817
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-27
Decision Date1997-06-27
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.