Home / 510(k) Clearances / K962290

510(k) K962290

DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER by Debusk Technology Corp. — Product Code FOK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1996
Date Received
June 14, 1996
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 Debusk Technology Corp.

  • K941250 — TROCAR AND CANNULA (May 6, 1994)
  • K940299 — ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUAL RETURN ELECTRODE W (May 2, 1994)
  • K940909 — ELECTROSURGICAL MONOPOLAR HANDSWITCHING PENCIL W/REMOVABLE BLADE (March 30, 1994)

Other clearances for product code FOK

  • K926118 — LIFE TRACE(R) BILIRUBIN MASK (March 15, 1993)
  • K851918 — INFANT PHOTOTHERAPY MASK (June 7, 1985)
  • K840894 — PHOTO-THERAPY EYE PROTECTOR (March 23, 1984)
  • K813214 — INFANT PHOTOTHERAPY MASK (December 9, 1981)