Procedure & Recovery Patient Suit

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K803171 ↗

FDA Product Code

FYB

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Alba Dry Burn Dressing

  Class I

  FDA 510(k) K850904 Active Cleared 17 Apr 1985

• Alba Health Care Non-Adhering Dressing

  Unclassified

  FDA 510(k) K850241 Active Cleared 12 Mar 1985

• Alba Health Care Iodoform Packing Strip

  Not classified

  FDA 510(k) K864689 Active Cleared 20 Jan 1987

• Sterile Orthopedic Stockinette

  Class I

  FDA 510(k) K812904 Active Cleared 18 Jan 1982

• Alba Dry Burn Pad

  Not classified

  FDA 510(k) K850881 Active Cleared 17 Apr 1985

• Alba Health Care Plain Packing Strip

  Unclassified

  FDA 510(k) K861154 Active Cleared 15 Apr 1986

See all devices from Alba Health Care →