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510(k) K042955

CUTICOVER SKIN BARRIER DEVICE by D & D Holdings, LLC — Product Code KMF

K042955 is an FDA 510(k) premarket notification submitted by D & D Holdings, LLC for the device "CUTICOVER SKIN BARRIER DEVICE". The FDA issued a decision of Substantially Equivalent on June 19, 2006. 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
June 19, 2006
Date Received
October 26, 2004
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 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)

FDA data resources