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510(k) K941263

COMFEEL PLUS WOUND DRESSING by Richard Hamer Assoc., Inc. — Product Code KMF

K941263 is an FDA 510(k) premarket notification submitted by Richard Hamer Assoc., Inc. for the device "COMFEEL PLUS WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on May 10, 1994. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Richard Hamer Assoc., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1994
Date Received
March 16, 1994
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 Richard Hamer Assoc., Inc.

  • K962439 — DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) (September 3, 1996)
  • K951325 — COMFEEL PLUS PRESSURE RELIEF DRESSING (July 31, 1995)
  • K950934 — MPM HYDROGEL DRESSING (May 16, 1995)
  • K951327 — COMFEEL PLUS CONTOUR DRESSING (April 28, 1995)
  • K942283 — COMFEEL PLUS TRANSPARENT DRESSING (July 29, 1994)
  • K942573 — COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH (July 18, 1994)
  • K934839 — MESALT STERILE DRESSING (December 22, 1993)

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