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510(k) K904604

REDI-RELEASE ABSORBENT DRESSING by Fountain Pharmaceuticals, Inc. — Product Code KOZ

K904604 is an FDA 510(k) premarket notification submitted by Fountain Pharmaceuticals, Inc. for the device "REDI-RELEASE ABSORBENT DRESSING". The FDA issued a decision of Substantially Equivalent on January 7, 1991. The device falls under product code KOZ (Beads, Hydrophilic, For Wound Exudate Absorption), a Class I device regulated under 21 CFR 878.4018. Fountain Pharmaceuticals, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1991
Date Received
October 10, 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 Fountain Pharmaceuticals, Inc.

  • K895654 — SORBEX(TM) SOFT SPONGE (February 20, 1990)

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)
  • 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)
  • K874552 — ENVISAN PAD (January 22, 1988)

FDA data resources