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510(k) K082703

MRDH BANDAGE by Marine Polymer Technologies, Inc. — Product Code KMF

K082703 is an FDA 510(k) premarket notification submitted by Marine Polymer Technologies, Inc. for the device "MRDH BANDAGE". The FDA issued a decision of Substantially Equivalent on October 14, 2008. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Marine Polymer Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2008
Date Received
September 16, 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 Marine Polymer Technologies, Inc.

  • K160695 — Talymed Suspension (December 6, 2016)
  • K132293 — SYVEK RADIAL BAND (July 31, 2014)
  • K111524 — MP 719 (July 22, 2011)
  • K102002 — TALYMED (July 28, 2010)
  • K070557 — MP 719 (May 23, 2007)
  • K053300 — SYVEKEXCEL (March 28, 2006)
  • K002550 — RDH BANDAGE (December 20, 2000)
  • K984177 — MODIFICATION TO SKVEKPATCH (December 18, 1998)
  • K972914 — SYVEK PATCH (December 22, 1997)

Other clearances for product code KMF

  • K241916 — TearRepair Liquid Skin Protectant (September 27, 2024)
  • 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