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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 a medical device manufactured by 3M Healthcare. It received FDA 510(k) clearance on 2017-08-10 under approval 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. It is manufactured by 3M Healthcare. The 510(k) number is K171116.

When was 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S approved by the FDA?

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

What company makes 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 manufactured by 3M Healthcare.

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.

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Other Devices by 3M Healthcare

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Related Devices (Code: MSH)

K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd. K172963Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd. 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.

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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