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510(k) K905314

ALGODERM ALGINATE WOUND DRESSING by Les Laboratorires Brothier, S.A. — Product Code FRO

K905314 is an FDA 510(k) premarket notification submitted by Les Laboratorires Brothier, S.A. for the device "ALGODERM ALGINATE WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on February 19, 1991. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Les Laboratorires Brothier, S.A. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1991
Date Received
November 28, 1990
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 Les Laboratorires Brothier, S.A.

  • K041446 — NASALCEASE (July 1, 2004)
  • K984069 — ENTAXIS NASAL PACKING (January 25, 1999)
  • K922540 — WOUND DRESSING (August 24, 1992)
  • K893123 — ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES (February 13, 1990)

Other clearances for product code FRO

  • 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)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources