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FDA 510(k)

JGH1 Core Deccompression Procedure Kit

K-Number: K181585 · 2018-07-20

ApplicantAgNovos Healthcare USA, LLC
Decision Date2018-07-20
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JGH1 Core Deccompression Procedure Kit is the device name listed in this FDA 510(k) record. The listed applicant is AgNovos Healthcare USA, LLC. It received FDA 510(k) clearance on 2018-07-20 under 510(k) number K181585. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JGH1 Core Deccompression Procedure Kit?

JGH1 Core Deccompression Procedure Kit is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is AgNovos Healthcare USA, LLC. The 510(k) number is K181585.

When did JGH1 Core Deccompression Procedure Kit receive FDA 510(k) clearance?

JGH1 Core Deccompression Procedure Kit received FDA 510(k) clearance on 2018-07-20, under 510(k) number K181585.

Who is the listed applicant for JGH1 Core Deccompression Procedure Kit?

The FDA 510(k) record lists AgNovos Healthcare USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JGH1 Core Deccompression Procedure Kit?

The FDA product code for JGH1 Core Deccompression Procedure Kit is MQV.

Other records listing AgNovos Healthcare USA, LLC 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.

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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.

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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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