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510(k) K970886

HANAULUX BLUE 80 HOSPITAL by Heraeus Med GmbH — Product Code FSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1997
Date Received
February 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Floor Standing
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Heraeus Med GmbH

  • K973466 — HANAULUX BLUE 75 AND HANAULUX BLUE 120 (October 24, 1997)
  • K954169 — HANAULUX BLUE 30 & 80 (February 1, 1996)

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  • K984124 — AESCULAP XENON LIGHT SOURCE (February 1, 1999)
  • K981962 — CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE (August 18, 1998)
  • K981821 — VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR (July 29, 1998)
  • K981469 — CERMAX300 LIGHTSOURCE (July 9, 1998)
  • K980044 — XENON 300MX (April 3, 1998)
  • K961971 — Q-5000 (June 28, 1996)
  • K961074 — LIGHTSOURCE OR ILLUMINATOR (April 30, 1996)
  • K930711 — TRI*STAR (July 30, 1993)