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510(k) K973466

HANAULUX BLUE 75 AND HANAULUX BLUE 120 by Heraeus Med GmbH — Product Code FSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1997
Date Received
August 15, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Heraeus Med GmbH

  • K970886 — HANAULUX BLUE 80 HOSPITAL (April 16, 1997)
  • K954169 — HANAULUX BLUE 30 & 80 (February 1, 1996)

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