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FDA 510(k)

SERIM DISINTEK GTA 2.1%, MODEL: 5164

K-Number: K083295 · 2009-03-16

ApplicantSerim Research Corp.
Decision Date2009-03-16
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SERIM DISINTEK GTA 2.1%, MODEL: 5164 is the device name listed in this FDA 510(k) record. The listed applicant is Serim Research Corp.. It received FDA 510(k) clearance on 2009-03-16 under 510(k) number K083295. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIM DISINTEK GTA 2.1%, MODEL: 5164?

SERIM DISINTEK GTA 2.1%, MODEL: 5164 is a medical device that received FDA 510(k) clearance on 2009-03-16. The listed applicant is Serim Research Corp.. The 510(k) number is K083295.

When did SERIM DISINTEK GTA 2.1%, MODEL: 5164 receive FDA 510(k) clearance?

SERIM DISINTEK GTA 2.1%, MODEL: 5164 received FDA 510(k) clearance on 2009-03-16, under 510(k) number K083295.

Who is the listed applicant for SERIM DISINTEK GTA 2.1%, MODEL: 5164?

The FDA 510(k) record lists Serim Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERIM DISINTEK GTA 2.1%, MODEL: 5164?

The FDA product code for SERIM DISINTEK GTA 2.1%, MODEL: 5164 is JOJ.

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Other records listing Serim Research Corp. as applicant

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Related Devices (Code: JOJ)

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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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