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510(k) K901876

INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) by Smith & Nephew United, Inc. — Product Code KOZ

Clearance Details

Decision
SN ()
Decision Date
June 28, 1990
Date Received
April 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.

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  • 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)
  • K904412 — ALLEVYN DRESSING CLAIMS CHANGE (October 23, 1990)
  • K896176 — EXUSORB(TM) DRY/WET DRESSING (November 24, 1989)
  • K895354 — INTRASITE CAVITY WOUND DRESSING (November 7, 1989)
  • K874552 — ENVISAN PAD (January 22, 1988)