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510(k) K993300

COLDLIGHTSOURCE PL3000 by Fiber Imaging Technologies, Inc. — Product Code FCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1999
Date Received
October 1, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Fiberoptic, Routine
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Fiber Imaging Technologies, Inc.

  • K992527 — URETERO-RENOSCOPE (October 13, 1999)
  • K992437 — SCHOELLY RIGID ENDOSCOPES (September 14, 1999)
  • K992040 — FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES (August 6, 1999)
  • K991560 — NASO-LARYNGO-PHARYNGOSCOPE (July 13, 1999)

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