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510(k) K896176

EXUSORB(TM) DRY/WET DRESSING by Controlled Therapeutics Corp. — Product Code KOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1989
Date Received
October 25, 1989
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 Controlled Therapeutics Corp.

  • K895606 — EXUSORB(TM) GEL DRESSING (October 19, 1989)
  • K894996 — EXUSORB(TM) GRANULES (September 28, 1989)
  • K894274 — EXUSORB TRANSPARENT DRESSING (August 18, 1989)

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)
  • K903645 — DERMASORB WOUND CONTACT LAYER DRESSING (November 21, 1990)
  • K896828 — BIOCLUSIVE(R) ABSORBENT DRESSING (November 21, 1990)
  • K904412 — ALLEVYN DRESSING CLAIMS CHANGE (October 23, 1990)
  • K901876 — INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) (June 28, 1990)
  • K895354 — INTRASITE CAVITY WOUND DRESSING (November 7, 1989)
  • K874552 — ENVISAN PAD (January 22, 1988)