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FDA 510(k)

A-Oss

K-Number: K151542 · 2016-08-03

ApplicantHiossen, Inc.
Decision Date2016-08-03
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A-Oss is a medical device manufactured by Hiossen, Inc.. It received FDA 510(k) clearance on 2016-08-03 under approval number K151542. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-Oss?

A-Oss is a medical device that received FDA 510(k) clearance on 2016-08-03. It is manufactured by Hiossen, Inc.. The 510(k) number is K151542.

When was A-Oss approved by the FDA?

A-Oss received FDA 510(k) clearance on 2016-08-03, under approval number K151542.

What company makes A-Oss?

A-Oss is manufactured by Hiossen, Inc..

What is the FDA product code for A-Oss?

The FDA product code for A-Oss is NPM.

Other Devices by Hiossen, Inc.

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Related Devices (Code: NPM)

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.