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510(k) K926118

LIFE TRACE(R) BILIRUBIN MASK by Graphic Controls Corp. — Product Code FOK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1993
Date Received
December 3, 1992
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 Graphic Controls Corp.

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  • K980857 — MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE (May 12, 1998)
  • K972970 — MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE (August 27, 1997)
  • K964387 — POINT OF USE II SHARPS-A-GATOR (March 27, 1997)
  • K964279 — SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) (January 22, 1997)
  • K963151 — MEDI-TRACE 5700 RESTING ECG ELECTRODE (November 19, 1996)
  • K963038 — MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE (November 15, 1996)
  • K960968 — MEDI-TRACE 200, MEDI-TRACE 200-30 (October 28, 1996)

Other clearances for product code FOK

  • K962290 — DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER (July 3, 1996)
  • K851918 — INFANT PHOTOTHERAPY MASK (June 7, 1985)
  • K840894 — PHOTO-THERAPY EYE PROTECTOR (March 23, 1984)
  • K813214 — INFANT PHOTOTHERAPY MASK (December 9, 1981)