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FDA 510(k)

Dukal Corporation Level 1 Pediatric Face Mask

K-Number: K210321 · 2022-03-29

ApplicantDukal Corporation
Decision Date2022-03-29
Product CodeOXZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dukal Corporation Level 1 Pediatric Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Dukal Corporation. It received FDA 510(k) clearance on 2022-03-29 under 510(k) number K210321. The device is classified under product code OXZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dukal Corporation Level 1 Pediatric Face Mask?

Dukal Corporation Level 1 Pediatric Face Mask is a medical device that received FDA 510(k) clearance on 2022-03-29. The listed applicant is Dukal Corporation. The 510(k) number is K210321.

When did Dukal Corporation Level 1 Pediatric Face Mask receive FDA 510(k) clearance?

Dukal Corporation Level 1 Pediatric Face Mask received FDA 510(k) clearance on 2022-03-29, under 510(k) number K210321.

Who is the listed applicant for Dukal Corporation Level 1 Pediatric Face Mask?

The FDA 510(k) record lists Dukal Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dukal Corporation Level 1 Pediatric Face Mask?

The FDA product code for Dukal Corporation Level 1 Pediatric Face Mask is OXZ.

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Related Devices (Code: OXZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221753Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd.K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc.K201514Child Face MaskShandong Shengquan New Material Co., Ltd.K202831The iMask Child's Face MaskPac-Dent, Inc.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.K160100Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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