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510(k) K850241

ALBA HEALTH CARE NON-ADHERING DRESSING by Alba Health Care — Product Code FRO

K850241 is an FDA 510(k) premarket notification submitted by Alba Health Care for the device "ALBA HEALTH CARE NON-ADHERING DRESSING". The FDA issued a decision of Substantially Equivalent on March 12, 1985. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Alba Health Care has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1985
Date Received
January 22, 1985
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 Alba Health Care

  • K864689 — ALBA HEALTH CARE IODOFORM PACKING STRIP (January 20, 1987)
  • K861154 — ALBA HEALTH CARE PLAIN PACKING STRIP (April 15, 1986)
  • K851918 — INFANT PHOTOTHERAPY MASK (June 7, 1985)
  • K850881 — ALBA DRY BURN PAD (April 17, 1985)
  • K850904 — ALBA DRY BURN DRESSING (April 17, 1985)
  • K812904 — STERILE ORTHOPEDIC STOCKINETTE (January 18, 1982)
  • K803171 — PROCEDURE & RECOVERY PATIENT SUIT (March 4, 1981)

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