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FDA 510(k)

LOW ADHERENT AFM AG DRESSINGS

K-Number: K103141 · 2011-01-21

ApplicantMilliken Healthcare Products, LLC
Decision Date2011-01-21
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

LOW ADHERENT AFM AG DRESSINGS is the device name listed in this FDA 510(k) record. The listed applicant is Milliken Healthcare Products, LLC. It received FDA 510(k) clearance on 2011-01-21 under 510(k) number K103141. 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 LOW ADHERENT AFM AG DRESSINGS?

LOW ADHERENT AFM AG DRESSINGS is a medical device that received FDA 510(k) clearance on 2011-01-21. The listed applicant is Milliken Healthcare Products, LLC. The 510(k) number is K103141.

When did LOW ADHERENT AFM AG DRESSINGS receive FDA 510(k) clearance?

LOW ADHERENT AFM AG DRESSINGS received FDA 510(k) clearance on 2011-01-21, under 510(k) number K103141.

Who is the listed applicant for LOW ADHERENT AFM AG DRESSINGS?

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

What is the FDA product code for LOW ADHERENT AFM AG DRESSINGS?

The FDA product code for LOW ADHERENT AFM AG DRESSINGS is FRO. This falls under the Anesthesiology category.

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Other records listing Milliken Healthcare Products, 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.

K110715INTERDRY SILVER

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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

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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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