DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560

Mask, Surgical

DUKAL CORP.

The following data is part of a premarket notification filed by Dukal Corp. with the FDA for Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; With Shield, Model 1560.

Pre-market Notification Details

Device IDK061864
510k NumberK061864
Device Name:DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560
ClassificationMask, Surgical
Applicant DUKAL CORP. 5 PLANT AVE Hauppauge,  NY  11788
ContactPatrick J Lamb
CorrespondentPatrick J Lamb
DUKAL CORP. 5 PLANT AVE Hauppauge,  NY  11788
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-03
Decision Date2006-09-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20607415001550 K061864 000
20607415001536 K061864 000
40607415001523 K061864 000
20607415001499 K061864 000
20607415001475 K061864 000
20607415001451 K061864 000

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