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510(k) K840894

PHOTO-THERAPY EYE PROTECTOR by A & A Medical Supplies Co. — Product Code FOK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1984
Date Received
February 27, 1984
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

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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)
  • K851918 — INFANT PHOTOTHERAPY MASK (June 7, 1985)
  • K813214 — INFANT PHOTOTHERAPY MASK (December 9, 1981)