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510(k) K880330

FERRIS HYDROPHILIC DRESSING by Ferris Mfg. Corp. — Product Code FRO

K880330 is an FDA 510(k) premarket notification submitted by Ferris Mfg. Corp. for the device "FERRIS HYDROPHILIC DRESSING". The FDA issued a decision of SN on March 23, 1988. 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
March 23, 1988
Date Received
January 27, 1988
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)
  • K874478 — DYNAFILM (January 14, 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