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FDA 510(k)

DS N95 SURGICAL MASKS AND FLAT SURGICAL

K-Number: K090131 · 2009-04-27

ApplicantShanghai Dasheng Health Products
Decision Date2009-04-27
Product CodeMSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DS N95 SURGICAL MASKS AND FLAT SURGICAL is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Dasheng Health Products. It received FDA 510(k) clearance on 2009-04-27 under 510(k) number K090131. 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 DS N95 SURGICAL MASKS AND FLAT SURGICAL?

DS N95 SURGICAL MASKS AND FLAT SURGICAL is a medical device that received FDA 510(k) clearance on 2009-04-27. The listed applicant is Shanghai Dasheng Health Products. The 510(k) number is K090131.

When did DS N95 SURGICAL MASKS AND FLAT SURGICAL receive FDA 510(k) clearance?

DS N95 SURGICAL MASKS AND FLAT SURGICAL received FDA 510(k) clearance on 2009-04-27, under 510(k) number K090131.

Who is the listed applicant for DS N95 SURGICAL MASKS AND FLAT SURGICAL?

The FDA 510(k) record lists Shanghai Dasheng Health Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DS N95 SURGICAL MASKS AND FLAT SURGICAL?

The FDA product code for DS N95 SURGICAL MASKS AND FLAT SURGICAL 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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