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510(k) K081009

NEUTROPHASE by Novabay Pharmaceuticals — Product Code KMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2008
Date Received
April 8, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type

Other clearances by Novabay Pharmaceuticals

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  • K131542 — NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC (July 24, 2013)
  • K113820 — NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER (August 8, 2012)
  • K071056 — NEUTROPHASE WOUND CLEANSER (September 28, 2007)

Other clearances for product code KMF

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  • K182733 — Rochal Bioshield Silicone Film (June 27, 2019)
  • K171148 — Aleo BME Liquid Bandage (January 12, 2018)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K160684 — Atteris No-Sting Skin Protectant (July 26, 2016)
  • K131384 — KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (August 7, 2014)
  • K133443 — MARATHON NO STING LIQUID SKIN PROTECTANT (July 10, 2014)
  • K120059 — LIQUID BANDAGE (May 17, 2012)
  • K092712 — SKIN BARRIER FILM (February 23, 2010)
  • K083087 — ECOCEL (August 7, 2009)