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510(k) K813535

XEROFORM DRESSING by W.G. Whitney Corp. — Product Code FRO

K813535 is an FDA 510(k) premarket notification submitted by W.G. Whitney Corp. for the device "XEROFORM DRESSING". The FDA issued a decision of Substantially Equivalent on February 4, 1982. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. W.G. Whitney Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1982
Date Received
December 17, 1981
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 W.G. Whitney Corp.

  • K834532 — STERILE WET DRESSING PACK (January 25, 1984)
  • K810406 — STERILE WET DRESSING PACK (March 11, 1981)
  • K803299 — COLD/HOT PACK (January 15, 1981)
  • K800907 — TOMAC WET DRESSING WARMER (May 20, 1980)
  • K781322 — STERILE WET DRESSING PACK (August 17, 1978)
  • K770387 — UNICATCH (April 5, 1977)

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