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510(k) K912252

INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT by Fiberoptic Medical Products, Inc. — Product Code FST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1991
Date Received
May 21, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Fiberoptic Medical Products, Inc.

  • K944686 — FIBEROPTIC LARYNGOSCOPE HANDLE (November 4, 1994)
  • K933598 — ENDOSTAR(TM) STYLET (January 25, 1994)
  • K921393 — IMAGICA MICRO-ENDOSCOPE (August 20, 1992)
  • K883779 — WALLABY(TM) BLANKET (November 14, 1988)

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