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510(k) K896961

HALUX EXLITE MINOR SURGERY LIGHT by Jedmed Instrument Co. — Product Code GBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1990
Date Received
December 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Surgical, Incandescent
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

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Other clearances for product code GBC

  • K830610 — FLAT SUCTION DRAIN (March 29, 1983)
  • K811311 — SKYTRON ELITE SURGICAL TABLES (June 2, 1981)
  • K810207 — MINOR SURGERY LIGHT (February 13, 1981)