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510(k) K983277

LIGHTSOURCE OR ILLUMINATOR MODEL I-100 by Cuda Products Co. — Product Code HBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1998
Date Received
September 17, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Fiberoptic, Surgical Field
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Cuda Products Co.

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  • K980166 — LIGHTSOURCE OR ILLUMINATOR (April 1, 1998)
  • K961074 — LIGHTSOURCE OR ILLUMINATOR (April 30, 1996)
  • K951019 — INTRAORAL VIDEO SCOPE AND WINDOW TUBE (May 10, 1995)
  • K943731 — VIDEO OTOSCOPE (October 11, 1994)
  • K935818 — ENDOSCOPE (July 13, 1994)
  • K933369 — CUDA PRODUCTS CORP. LIGHTSOURCES (January 3, 1994)
  • K934337 — CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE (November 18, 1993)

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