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FDA 510(k)

THERABOND ANTIMICROBIAL BARRIER SYSTEMS

K-Number: K073213 · 2008-05-28

ApplicantChoice Therapeutics
Decision Date2008-05-28
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

THERABOND ANTIMICROBIAL BARRIER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Choice Therapeutics. It received FDA 510(k) clearance on 2008-05-28 under 510(k) number K073213. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERABOND ANTIMICROBIAL BARRIER SYSTEMS?

THERABOND ANTIMICROBIAL BARRIER SYSTEMS is a medical device that received FDA 510(k) clearance on 2008-05-28. The listed applicant is Choice Therapeutics. The 510(k) number is K073213.

When did THERABOND ANTIMICROBIAL BARRIER SYSTEMS receive FDA 510(k) clearance?

THERABOND ANTIMICROBIAL BARRIER SYSTEMS received FDA 510(k) clearance on 2008-05-28, under 510(k) number K073213.

Who is the listed applicant for THERABOND ANTIMICROBIAL BARRIER SYSTEMS?

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

What is the FDA product code for THERABOND ANTIMICROBIAL BARRIER SYSTEMS?

The FDA product code for THERABOND ANTIMICROBIAL BARRIER SYSTEMS is FRO. This falls under the Anesthesiology category.

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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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