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FDA 510(k)

N5-1

K-Number: K153054 · 2016-02-05

ApplicantNuga Medical Co., Ltd.
Decision Date2016-02-05
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

N5-1 is a medical device manufactured by Nuga Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-02-05 under approval number K153054. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N5-1?

N5-1 is a medical device that received FDA 510(k) clearance on 2016-02-05. It is manufactured by Nuga Medical Co., Ltd.. The 510(k) number is K153054.

When was N5-1 approved by the FDA?

N5-1 received FDA 510(k) clearance on 2016-02-05, under approval number K153054.

What company makes N5-1?

N5-1 is manufactured by Nuga Medical Co., Ltd..

What is the FDA product code for N5-1?

The FDA product code for N5-1 is JFB.

Other Devices by Nuga Medical Co., Ltd.

K240168N7-S

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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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