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FDA 510(k)

General & Plastic Surgery Instruments

K-Number: K152400 · 2016-01-22

ApplicantSontec Instruments, Inc.
Decision Date2016-01-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

General & Plastic Surgery Instruments is a medical device manufactured by Sontec Instruments, Inc.. It received FDA 510(k) clearance on 2016-01-22 under approval number K152400. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the General & Plastic Surgery Instruments?

General & Plastic Surgery Instruments is a medical device that received FDA 510(k) clearance on 2016-01-22. It is manufactured by Sontec Instruments, Inc.. The 510(k) number is K152400.

When was General & Plastic Surgery Instruments approved by the FDA?

General & Plastic Surgery Instruments received FDA 510(k) clearance on 2016-01-22, under approval number K152400.

What company makes General & Plastic Surgery Instruments?

General & Plastic Surgery Instruments is manufactured by Sontec Instruments, Inc..

What is the FDA product code for General & Plastic Surgery Instruments?

The FDA product code for General & Plastic Surgery Instruments is GCJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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