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510(k) K870559

IODOSORB POWDER by Perstorp AB C/O Robert Joel Slomoff — Product Code KOZ

K870559 is an FDA 510(k) premarket notification submitted by Perstorp AB C/O Robert Joel Slomoff for the device "IODOSORB POWDER". The FDA issued a decision of SN on March 20, 1987. The device falls under product code KOZ (Beads, Hydrophilic, For Wound Exudate Absorption), a Class I device regulated under 21 CFR 878.4018. Perstorp AB C/O Robert Joel Slomoff has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SN ()
Decision Date
March 20, 1987
Date Received
February 10, 1987
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 Perstorp AB C/O Robert Joel Slomoff

  • K905069 — IODOSORB GEL (January 31, 1991)

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)
  • 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)

FDA data resources