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510(k) K833730

NON ADHERENT BANDAGE/SHEET by American Medical Disposable, Inc. — Product Code FRO

K833730 is an FDA 510(k) premarket notification submitted by American Medical Disposable, Inc. for the device "NON ADHERENT BANDAGE/SHEET". The FDA issued a decision of Substantially Equivalent on January 27, 1984. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. American Medical Disposable, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1984
Date Received
October 25, 1983
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 American Medical Disposable, Inc.

  • K833735 — AN ODOR ABSORBENT BANDAGE (April 23, 1984)
  • K833734 — NEUROLOGICAL SPONGE ON PLASTIC STICK (April 23, 1984)
  • K833731 — BREATHABLE OVERWRAY BANDAGE NON-ELAS (January 27, 1984)
  • K833729 — ELASTIC BREATHABLE OVER-WRAP BANDAGE (December 30, 1983)
  • K833733 — NON - ADHERENT BANDAGE (December 27, 1983)
  • K833732 — NON WETTING UNDERCAST PADDING (December 12, 1983)
  • K830201 — POLYESTER X-RAY DETECTABLE STRUNG-SPONGE (February 23, 1983)
  • K830202 — COTTON BALLS, X-RAY OPAQUED STRUNG & NON (February 23, 1983)
  • K803116 — HEAVY DRAINAGE PACK (January 28, 1981)
  • K803115 — DRESSING CHANGE FOR G TUBE (January 6, 1981)

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