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FDA 510(k)

HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810

K-Number: K080827 · 2008-04-04

ApplicantHandan Hengyong Protective & Clean Products Co., L
Decision Date2008-04-04
Product CodeMSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 is the device name listed in this FDA 510(k) record. The listed applicant is Handan Hengyong Protective & Clean Products Co., L. It received FDA 510(k) clearance on 2008-04-04 under 510(k) number K080827. 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 HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810?

HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 is a medical device that received FDA 510(k) clearance on 2008-04-04. The listed applicant is Handan Hengyong Protective & Clean Products Co., L. The 510(k) number is K080827.

When did HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 receive FDA 510(k) clearance?

HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 received FDA 510(k) clearance on 2008-04-04, under 510(k) number K080827.

Who is the listed applicant for HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810?

The FDA 510(k) record lists Handan Hengyong Protective & Clean Products Co., L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810?

The FDA product code for HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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