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510(k) K885321

WATER JEL STERILE GEL-SOAKED BURN DRESSING by Pfizer Pharmaceuticals — Product Code FRO

K885321 is an FDA 510(k) premarket notification submitted by Pfizer Pharmaceuticals for the device "WATER JEL STERILE GEL-SOAKED BURN DRESSING". The FDA issued a decision of SN on March 22, 1989. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Pfizer Pharmaceuticals has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
March 22, 1989
Date Received
December 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Pfizer Pharmaceuticals

  • K810427 — CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP. (March 31, 1981)
  • K802408 — E-VAC BLOOD CULTURE SYSTEM (October 23, 1980)
  • K771605 — CREATINE KINASE ISOENZYME SUBSTRATE SET (September 15, 1977)
  • K770801 — MICROBIO. PROD. FLUORESCENT ANTIBODY (May 25, 1977)
  • K770425 — NEEDLES, STERILE, AIRWAY (April 15, 1977)

Other clearances for product code FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources