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510(k) K904412

ALLEVYN DRESSING CLAIMS CHANGE by Smith & Nephew United, Inc. — Product Code KOZ

K904412 is an FDA 510(k) premarket notification submitted by Smith & Nephew United, Inc. for the device "ALLEVYN DRESSING CLAIMS CHANGE". The FDA issued a decision of SN on October 23, 1990. The device falls under product code KOZ (Beads, Hydrophilic, For Wound Exudate Absorption), a Class I device regulated under 21 CFR 878.4018. Smith & Nephew United, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
October 23, 1990
Date Received
September 26, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Beads, Hydrophilic, For Wound Exudate Absorption
Device Class
Class I
Regulation Number
878.4018
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 KOZ

  • K905206 — INCARE PINSITE DRESSING (April 12, 1991)
  • K905688 — CUTINOVA HYDRO (April 1, 1991)
  • K905069 — IODOSORB GEL (January 31, 1991)
  • K904604 — REDI-RELEASE ABSORBENT DRESSING (January 7, 1991)
  • K896828 — BIOCLUSIVE(R) ABSORBENT DRESSING (November 21, 1990)
  • K903645 — DERMASORB WOUND CONTACT LAYER DRESSING (November 21, 1990)
  • K901876 — INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) (June 28, 1990)
  • K896176 — EXUSORB(TM) DRY/WET DRESSING (November 24, 1989)
  • K895354 — INTRASITE CAVITY WOUND DRESSING (November 7, 1989)
  • K874552 — ENVISAN PAD (January 22, 1988)

FDA data resources