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510(k) K865089

FERRIS DYNADERM PLUS by Ferris Mfg. Corp. — Product Code FRO

K865089 is an FDA 510(k) premarket notification submitted by Ferris Mfg. Corp. for the device "FERRIS DYNADERM PLUS". The FDA issued a decision of SN on February 4, 1987. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Ferris Mfg. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
February 4, 1987
Date Received
December 30, 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 Ferris Mfg. Corp.

  • K031660 — FERRIS POLYMEM STERILE BREAST PAD (February 22, 2005)
  • K031307 — FERRIS POLYMEM SILVER WOUND DRESSING (October 22, 2003)
  • K002129 — FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN (August 25, 2000)
  • K991729 — FERRIS POLYOSTOMY STERILE WOUND DRESSING (August 27, 1999)
  • K990906 — FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER (April 29, 1999)
  • K984539 — FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING (March 1, 1999)
  • K982306 — POLYTUBE (September 22, 1998)
  • K932913 — FERRIS POLYMEM HYDROPHILIC WOUND DRESSING (June 7, 1994)
  • K900127 — FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS) (May 18, 1990)
  • K880330 — FERRIS HYDROPHILIC DRESSING (March 23, 1988)

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