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FDA 510(k)

Sterile NS System

K-Number: K170368 · 2017-09-11

ApplicantJeil Medical Corporation
Decision Date2017-09-11
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sterile NS System is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2017-09-11 under 510(k) number K170368. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile NS System?

Sterile NS System is a medical device that received FDA 510(k) clearance on 2017-09-11. The listed applicant is Jeil Medical Corporation. The 510(k) number is K170368.

When did Sterile NS System receive FDA 510(k) clearance?

Sterile NS System received FDA 510(k) clearance on 2017-09-11, under 510(k) number K170368.

Who is the listed applicant for Sterile NS System?

The FDA 510(k) record lists Jeil Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile NS System?

The FDA product code for Sterile NS System is GWO.

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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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