NEUTROPHASE— 510(k) K081009

Substantially Equivalent

Novabay Pharmaceuticals

FDA 510(k) clearance K081009 for NEUTROPHASE, Substantially Equivalent on 2008-05-20. Applicant: Novabay Pharmaceuticals. Device class: 1.

Clearance details

Applicant: Novabay Pharmaceuticals
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 2008-04-08
Decision date: 2008-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Emeryville, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMF

K241916 — TearRepair Liquid Skin Protectant2024-09-27
K182733 — Rochal Bioshield Silicone Film2019-06-27
K171148 — Aleo BME Liquid Bandage2018-01-12
K153571 — Cavilon Advanced High Endurance Skin Protectant2016-08-23
K160684 — Atteris No-Sting Skin Protectant2016-07-26

More clearances from Novabay Pharmaceuticals

K113820 — NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER2012-08-08
K071056 — NEUTROPHASE WOUND CLEANSER2007-09-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.