Home / 510(k) Clearances / K942283

510(k) K942283

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

K942283 is an FDA 510(k) premarket notification submitted by Richard Hamer Assoc., Inc. for the device "COMFEEL PLUS TRANSPARENT DRESSING". The FDA issued a decision of SN on July 29, 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
SN ()
Decision Date
July 29, 1994
Date Received
May 11, 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)
  • K942573 — COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH (July 18, 1994)
  • K941263 — COMFEEL PLUS WOUND DRESSING (May 10, 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