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510(k) K182733

Rochal Bioshield Silicone Film by Rochal Industries, LLC — Product Code KMF

K182733 is an FDA 510(k) premarket notification submitted by Rochal Industries, LLC for the device "Rochal Bioshield Silicone Film". The FDA issued a decision of Substantially Equivalent on June 27, 2019. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Rochal Industries, LLC has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2019
Date Received
September 28, 2018
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 Rochal Industries, LLC

  • K192527 — Rochal Antimicrobial Wound Gel (February 7, 2020)
  • K161212 — Atteris Antimicrobial Skin Protectant (September 30, 2016)
  • K160192 — Atteris Antimicrobial Skin & Wound Cleanser (July 28, 2016)
  • K160684 — Atteris No-Sting Skin Protectant (July 26, 2016)

Other clearances for product code KMF

  • K241916 — TearRepair Liquid Skin Protectant (September 27, 2024)
  • 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)
  • K083913 — CHESSON LABS LIQUID BANDAGE (July 31, 2009)

FDA data resources