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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 a medical device manufactured by San-M Package Co., Ltd.. It received FDA 510(k) clearance on 2016-07-15 under approval 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. It is manufactured by San-M Package Co., Ltd.. The 510(k) number is K160271.

When was N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 approved by the FDA?

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

What company makes 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 manufactured by San-M Package Co., Ltd..

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.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by San-M Package Co., Ltd.

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

Related Devices (Code: MSH)

K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S3M Healthcare 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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