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FDA 510(k)

NEUTROPHASE

K-Number: K081009 · 2008-05-20

ApplicantNovabay Pharmaceuticals
Decision Date2008-05-20
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEUTROPHASE is the device name listed in this FDA 510(k) record. The listed applicant is Novabay Pharmaceuticals. It received FDA 510(k) clearance on 2008-05-20 under 510(k) number K081009. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUTROPHASE?

NEUTROPHASE is a medical device that received FDA 510(k) clearance on 2008-05-20. The listed applicant is Novabay Pharmaceuticals. The 510(k) number is K081009.

When did NEUTROPHASE receive FDA 510(k) clearance?

NEUTROPHASE received FDA 510(k) clearance on 2008-05-20, under 510(k) number K081009.

Who is the listed applicant for NEUTROPHASE?

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

What is the FDA product code for NEUTROPHASE?

The FDA product code for NEUTROPHASE is KMF.

Related Clinical Trials

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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Other records listing Novabay Pharmaceuticals 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.

K113820NEUTROPHASE ANTIMICROBIAL WOUND CLEANSERK071056NEUTROPHASE WOUND CLEANSER

Related Devices (Code: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, Inc.

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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