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510(k) K991729

FERRIS POLYOSTOMY STERILE WOUND DRESSING by Ferris Mfg. Corp. — Product Code KMF

K991729 is an FDA 510(k) premarket notification submitted by Ferris Mfg. Corp. for the device "FERRIS POLYOSTOMY STERILE WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on August 27, 1999. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Ferris Mfg. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1999
Date Received
May 20, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
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)
  • 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)
  • K874478 — DYNAFILM (January 14, 1988)

Other clearances for product code KMF

  • K241916 — TearRepair Liquid Skin Protectant (September 27, 2024)
  • K182733 — Rochal Bioshield Silicone Film (June 27, 2019)
  • K171148 — Aleo BME Liquid Bandage (January 12, 2018)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K160684 — Atteris No-Sting Skin Protectant (July 26, 2016)
  • K131384 — KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (August 7, 2014)
  • K133443 — MARATHON NO STING LIQUID SKIN PROTECTANT (July 10, 2014)
  • K120059 — LIQUID BANDAGE (May 17, 2012)
  • K092712 — SKIN BARRIER FILM (February 23, 2010)
  • K083087 — ECOCEL (August 7, 2009)

FDA data resources