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FDA 510(k)

CHLORASHIELD TM ANTIMICROBIAL DRESSING

K-Number: K103106 · 2011-03-30

ApplicantCare Fusion 213, LLC
Decision Date2011-03-30
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

CHLORASHIELD TM ANTIMICROBIAL DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion 213, LLC. It received FDA 510(k) clearance on 2011-03-30 under 510(k) number K103106. 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 CHLORASHIELD TM ANTIMICROBIAL DRESSING?

CHLORASHIELD TM ANTIMICROBIAL DRESSING is a medical device that received FDA 510(k) clearance on 2011-03-30. The listed applicant is Care Fusion 213, LLC. The 510(k) number is K103106.

When did CHLORASHIELD TM ANTIMICROBIAL DRESSING receive FDA 510(k) clearance?

CHLORASHIELD TM ANTIMICROBIAL DRESSING received FDA 510(k) clearance on 2011-03-30, under 510(k) number K103106.

Who is the listed applicant for CHLORASHIELD TM ANTIMICROBIAL DRESSING?

The FDA 510(k) record lists Care Fusion 213, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHLORASHIELD TM ANTIMICROBIAL DRESSING?

The FDA product code for CHLORASHIELD TM ANTIMICROBIAL DRESSING is FRO. This falls under the Anesthesiology category.

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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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