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510(k) K890716

LUXTEC ACO SERIES 4000 LIGHT SOURCE by Luxtec Corp. — Product Code FCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1989
Date Received
February 13, 1989
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 Luxtec Corp.

  • K973193 — LUXSCOPE (November 21, 1997)
  • K970642 — TENOSCOPE (May 21, 1997)
  • K970562 — TENOSNARE (May 14, 1997)
  • K950960 — REDDY ILLUMINATOR (September 8, 1995)
  • K895248 — IMS5000 ILLUMINATED LOUPES (September 15, 1989)
  • K864387 — LUXTEC FIBEROPTIC CABLES (May 22, 1987)
  • K864382 — FRAZIER SUCTION TUBE (January 14, 1987)
  • K864383 — LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS (January 14, 1987)
  • K864385 — LUXTEC LIGHT SOURCES (January 13, 1987)
  • K864865 — SPECULUM, VAGINAL, METAL FIBEROPTIC (January 9, 1987)

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