FDA.reportPublic FDA data

510(k) K210321

Device
Dukal Corporation Level 1 Pediatric Face Mask
Applicant
Dukal Corporation
510(k) number
K210321
Product code
OXZ
Decision
Substantially Equivalent (SESE)
Decision date
2022-03-29
Date received
2021-02-04
Regulation
878.4040
Classification name
Pediatric/Child Facemask
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Megan Quevedo
Address
2 Fleetwood Ct. Ronkonkoma NY US 11779 11779

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OXZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221753Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd.2023-12-21
K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc.2022-11-22
K201514Child Face MaskShandong Shengquan New Material Co., Ltd.2021-10-10
K202831The iMask Child's Face MaskPac-Dent, Inc.2021-08-26
K190308Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)Amd Medicom, Inc.2019-09-17
K160100Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech2016-10-07
K113340KIMBERLY-CLARK CHILD'S FACEMASKKimberly-Clark2012-05-04
K103150KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASKKimberly-Clark2011-09-23