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510(k) K760469

CLEANSING AGENT, NEW WOUND (DEBRISSU) by Pharmaseal Laboratories — Product Code KOZ

K760469 is an FDA 510(k) premarket notification submitted by Pharmaseal Laboratories for the device "CLEANSING AGENT, NEW WOUND (DEBRISSU)". The FDA issued a decision of Substantially Equivalent on December 16, 1976. The device falls under product code KOZ (Beads, Hydrophilic, For Wound Exudate Absorption), a Class I device regulated under 21 CFR 878.4018. Pharmaseal Laboratories has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1976
Date Received
August 19, 1976
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 Pharmaseal Laboratories

  • K800737 — DEBRISAN (DEXTRANOMER) PASTE (August 4, 1980)
  • K801146 — SAMPLING KIT (June 4, 1980)
  • K800874 — PELVIC EXAM TRAY (May 8, 1980)
  • K800362 — FLUID DISPENSING SYSTEM (March 12, 1980)

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