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510(k) K971953

CONFOSCAN by Tomey Corporation USA — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1997
Date Received
May 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

Other clearances by Tomey Corporation USA

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  • K961805 — TOMEY DTL ELECTRODE (May 9, 1997)
  • K932571 — TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 (August 31, 1995)
  • K945959 — VIDEO VISION ANALYZER (VIVA), VRB 100 (March 1, 1995)
  • K944910 — TOMEY EM-1000 SPECULAR MICROSCOPE (November 22, 1994)
  • K924760 — TOMEY PROTON TONOMETER (April 5, 1993)
  • K921815 — TOMEY PE-300 PORTABLE ERG (July 15, 1992)
  • K912112 — PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 (June 17, 1991)

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