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FDA 510(k)

NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC

K-Number: K131542 · 2013-07-24

ApplicantNovabay Pharmaceuticals, Inc.
Decision Date2013-07-24
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC is the device name listed in this FDA 510(k) record. The listed applicant is Novabay Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2013-07-24 under 510(k) number K131542. 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 NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC?

NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC is a medical device that received FDA 510(k) clearance on 2013-07-24. The listed applicant is Novabay Pharmaceuticals, Inc.. The 510(k) number is K131542.

When did NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC receive FDA 510(k) clearance?

NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC received FDA 510(k) clearance on 2013-07-24, under 510(k) number K131542.

Who is the listed applicant for NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC?

The FDA 510(k) record lists Novabay Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC?

The FDA product code for NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC is FRO. This falls under the Anesthesiology category.

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Related Devices (Code: FRO)

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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