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510(k) K872453

DEBRISAN ABSORBENT PAD by Pharmacia, Inc. — Product Code KOZ

K872453 is an FDA 510(k) premarket notification submitted by Pharmacia, Inc. for the device "DEBRISAN ABSORBENT PAD". The FDA issued a decision of SN on January 14, 1988. The device falls under product code KOZ (Beads, Hydrophilic, For Wound Exudate Absorption), a Class I device regulated under 21 CFR 878.4018. Pharmacia, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
January 14, 1988
Date Received
June 23, 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 Pharmacia, Inc.

  • K974350 — ALLERGAN IMMUNO CAP M4, M8, K70 (February 9, 1998)
  • K972364 — UNICAP PHADIATOP (September 4, 1997)
  • K972068 — UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 (July 3, 1997)
  • K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.0 (June 30, 1997)
  • K964152 — UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH (April 23, 1997)
  • K962274 — UNICAP 100 (September 12, 1996)
  • K941993 — PHARMACIA CAP SYSTEM PHADIATOP FEIA (January 30, 1996)
  • K954337 — GENOTROPIN MIXER (November 13, 1995)
  • K951025 — PISTON SYRINGE (October 19, 1995)
  • K952025 — ROBOCAP (July 26, 1995)

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