DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK

Respirator, Surgical

DUKAL CORPORATION

The following data is part of a premarket notification filed by Dukal Corporation with the FDA for Dukal N95particulate Respirator/surgical Face Mask.

Pre-market Notification Details

Device IDK070692
510k NumberK070692
Device Name:DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK
ClassificationRespirator, Surgical
Applicant DUKAL CORPORATION 5 PLANT AVENUE Hauppauge,  NY  11788
ContactPatrick J Lamb
CorrespondentPatrick J Lamb
DUKAL CORPORATION 5 PLANT AVENUE Hauppauge,  NY  11788
Product CodeMSH  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-13
Decision Date2007-05-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10665973005772 K070692 000
10665973005598 K070692 000
10665973005574 K070692 000

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