FDA 510(k)

DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK

K-Number: K070692 · 2007-05-30

Decision Date2007-05-30

Product CodeMSH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DUKAL N95PARTICULATE RESPIRATOR/SURGICAL 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 2007-05-30 under 510(k) number K070692. The device is classified under product code MSH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK?

DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK is a medical device that received FDA 510(k) clearance on 2007-05-30. The listed applicant is Dukal Corporation. The 510(k) number is K070692.

When did DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK receive FDA 510(k) clearance?

DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK received FDA 510(k) clearance on 2007-05-30, under 510(k) number K070692.

Who is the listed applicant for DUKAL N95PARTICULATE RESPIRATOR/SURGICAL 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 N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK?

The FDA product code for DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK is MSH.

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Other records listing Dukal Corporation as applicant

K212464Dukal Corporation AAMI Level 4 Open-Back Protective Gown K210321Dukal Corporation Level 1 Pediatric Face Mask K203237Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown K201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On K201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons K113689DUKAL LUBRICATING JELLY

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Related Devices (Code: MSH)

K233022Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and SmallOwens & Minor (O&M) Halyard, Inc.K172963Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd.K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S3M Healthcare K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd.K1210693M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK3M Company K102923BARRIER N95 PARTICULATE RESPIRATORMolnlycke Health Care

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.