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FDA 510(k)

PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S

K-Number: K041855 · 2004-11-10

ApplicantAearo Co.
Decision Date2004-11-10
Product CodeMSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S is the device name listed in this FDA 510(k) record. The listed applicant is Aearo Co.. It received FDA 510(k) clearance on 2004-11-10 under 510(k) number K041855. 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 PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S?

PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S is a medical device that received FDA 510(k) clearance on 2004-11-10. The listed applicant is Aearo Co.. The 510(k) number is K041855.

When did PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S receive FDA 510(k) clearance?

PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S received FDA 510(k) clearance on 2004-11-10, under 510(k) number K041855.

Who is the listed applicant for PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S?

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

What is the FDA product code for PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S?

The FDA product code for PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S is MSH.

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Related Devices (Code: MSH)

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.

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 HealthcareK160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd.K1210693M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK3M CompanyK102923BARRIER N95 PARTICULATE RESPIRATORMolnlycke Health Care

Official Source

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