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FDA 510(k)

3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S

K-Number: K171116 · 2017-08-10

Applicant3M Healthcare
Decision Date2017-08-10
Product CodeMSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 2017-08-10 under 510(k) number K171116. 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 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S?

3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S is a medical device that received FDA 510(k) clearance on 2017-08-10. The listed applicant is 3M Healthcare. The 510(k) number is K171116.

When did 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S receive FDA 510(k) clearance?

3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S received FDA 510(k) clearance on 2017-08-10, under 510(k) number K171116.

Who is the listed applicant for 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S?

The FDA 510(k) record lists 3M Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S?

The FDA product code for 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S is MSH.

Other records listing 3M Healthcare as applicant

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.

K1931103M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EK1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure MaskK1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face ShieldK1804043M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance SystemK153571Cavilon Advanced High Endurance Skin Protectant

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.K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd.

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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