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510(k) K040853

PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 by International Hospital Supply Co. — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2004
Date Received
April 1, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Neonatal Phototherapy
Device Class
Class II
Regulation Number
880.5700
Review Panel
HO
Submission Type

Other clearances by International Hospital Supply Co.

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  • K911377 — FORCEPS, COAGULATION, BIPOLAR, MALIS (April 19, 1991)
  • K910621 — BLADES FOR SPINAL LAMINECTOMY RETRACTOR (April 1, 1991)

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