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510(k) K851918

INFANT PHOTOTHERAPY MASK by Alba Health Care — Product Code FOK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1985
Date Received
May 2, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Neonatal Eye
Device Class
Class I
Regulation Number
880.5270
Review Panel
HO
Submission Type

Other clearances by Alba Health Care

  • K864689 — ALBA HEALTH CARE IODOFORM PACKING STRIP (January 20, 1987)
  • K861154 — ALBA HEALTH CARE PLAIN PACKING STRIP (April 15, 1986)
  • K850881 — ALBA DRY BURN PAD (April 17, 1985)
  • K850904 — ALBA DRY BURN DRESSING (April 17, 1985)
  • K850241 — ALBA HEALTH CARE NON-ADHERING DRESSING (March 12, 1985)
  • K812904 — STERILE ORTHOPEDIC STOCKINETTE (January 18, 1982)
  • K803171 — PROCEDURE & RECOVERY PATIENT SUIT (March 4, 1981)

Other clearances for product code FOK

  • K962290 — DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER (July 3, 1996)
  • K926118 — LIFE TRACE(R) BILIRUBIN MASK (March 15, 1993)
  • K840894 — PHOTO-THERAPY EYE PROTECTOR (March 23, 1984)
  • K813214 — INFANT PHOTOTHERAPY MASK (December 9, 1981)