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510(k) K171148

Aleo BME Liquid Bandage by Aleo Bme, Inc. — Product Code KMF

K171148 is an FDA 510(k) premarket notification submitted by Aleo Bme, Inc. for the device "Aleo BME Liquid Bandage". The FDA issued a decision of Substantially Equivalent on January 12, 2018. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2018
Date Received
April 19, 2017
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

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  • 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)
  • K083913 — CHESSON LABS LIQUID BANDAGE (July 31, 2009)

FDA data resources