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FDA 510(k)

N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12

K-Number: K160271 · 2016-07-15

ApplicantSan-M Package Co., Ltd.
Decision Date2016-07-15
Product CodeMSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 is the device name listed in this FDA 510(k) record. The listed applicant is San-M Package Co., Ltd.. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K160271. 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 N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12?

N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is San-M Package Co., Ltd.. The 510(k) number is K160271.

When did N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 receive FDA 510(k) clearance?

N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 received FDA 510(k) clearance on 2016-07-15, under 510(k) number K160271.

Who is the listed applicant for N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12?

The FDA 510(k) record lists San-M Package Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12?

The FDA product code for N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 is MSH.

Related Clinical Trials

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.

NCT07711145Reusable, Transparent, and Reconfigurable N95-equivalent Respirator Masks: Design, Fabrication, and Trials for Enhanced AdoptionCOMPLETED

Other records listing San-M Package Co., Ltd. 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.

K221534Surgical Face Masks (Ear Loops And Tie-On)K160269Surgical Face Masks (Ear loops and Tie-on)

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 Healthcare

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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