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510(k) K864841

WATER-JEL(R) BURN DRESSING by Trilling Resources, Ltd. — Product Code FRO

K864841 is an FDA 510(k) premarket notification submitted by Trilling Resources, Ltd. for the device "WATER-JEL(R) BURN DRESSING". The FDA issued a decision of SN on January 22, 1988. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Trilling Resources, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SN ()
Decision Date
January 22, 1988
Date Received
December 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Trilling Resources, Ltd.

  • K800064 — WATER JEL FIRE BLANKET (March 25, 1980)

Other clearances for product code FRO

  • K254041 — SkinSmart Antimicrobial HydroGel (September 11, 2026)
  • K261646 — Redermax® Antibacterial Wound Matrix (August 14, 2026)
  • K253665 — Vashe Plus Antimicrobial Solution (August 11, 2026)
  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)

FDA data resources