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510(k) K840745

STERILE ABSORBENT GAUZE BURN & SOUND by Chesebrough-Pond'S U.S.A. Co. — Product Code FRO

K840745 is an FDA 510(k) premarket notification submitted by Chesebrough-Pond'S U.S.A. Co. for the device "STERILE ABSORBENT GAUZE BURN & SOUND". The FDA issued a decision of Substantially Equivalent on April 23, 1984. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Chesebrough-Pond'S U.S.A. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1984
Date Received
February 22, 1984
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 Chesebrough-Pond'S U.S.A. Co.

  • K863866 — RESPIRADYNE II(TM) (January 28, 1987)
  • K862803 — CHESEBROUGH POND'S HYDROCOLLOID DRESSING (November 14, 1986)
  • K851383 — BLISTERFILM TRANSPARENT DRESSING (July 5, 1985)
  • K851382 — CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING (July 5, 1985)
  • K851539 — CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO (June 12, 1985)
  • K843567 — KANGAROO NASOGASTRIC FEEDING TUBE (February 14, 1985)
  • K845010 — CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH (January 15, 1985)
  • K844186 — CONTINENT STOMA SYSTEM & ACCESSORIES (January 15, 1985)
  • K844789 — KANGAROO ACCESS II ENTERAL FEEDING CONTAINER (January 2, 1985)
  • K843128 — FEMALE URINARY INCONTINENCE SYS (January 2, 1985)

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