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510(k) K904411

INTRASITE GEL (LABELING REVISION) by Smith & Nephew United, Inc. — Product Code KMF

K904411 is an FDA 510(k) premarket notification submitted by Smith & Nephew United, Inc. for the device "INTRASITE GEL (LABELING REVISION)". The FDA issued a decision of SN on November 26, 1990. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Smith & Nephew United, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
November 26, 1990
Date Received
September 26, 1990
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 Smith & Nephew United, Inc.

  • K963096 — ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING (October 25, 1996)
  • K961775 — PROFORE FOUR-LAYER BANDAGE SYSTEM KIT (July 16, 1996)
  • K945330 — ALLEVYN ADHESIVE (February 9, 1995)
  • K943619 — CAVI-CARE CONFORMING FOAM DRESSING (August 19, 1994)
  • K942748 — INTRASITE (June 29, 1994)
  • K935705 — ALLEVYN ISLAND WOUND DRESSING (February 15, 1994)
  • K935803 — CICA-CARE SILICONE GEL SHEET (February 3, 1994)
  • K932263 — SOLOSITE DERMAL WOUND GEL (October 1, 1993)
  • K926508 — INTRASITE GEL (July 13, 1993)
  • K922897 — STRAPPAL (September 15, 1992)

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