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510(k) K920167

NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL by Nextec Corp. — Product Code HBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1992
Date Received
January 10, 1992
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 Nextec Corp.

  • K922462 — NEXTEC FIBEROPTIC CABLES (September 21, 1992)
  • K921646 — NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON (May 13, 1992)

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