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510(k) K924779

BURTON KERATOMETER - MODLE 2040 by R.H. Burton Co. — Product Code HJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1993
Date Received
September 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Measuring, Corneal Radius
Device Class
Class I
Regulation Number
886.1450
Review Panel
OP
Submission Type

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  • K924786 — BURTON TRIAL LENS SET (April 14, 1993)
  • K924785 — BURTON RADIUSGAUGE - MODEL 2030 (April 5, 1993)
  • K924777 — BURTON APPLANATION TONOMETER - MODEL T850 & T1000 (April 5, 1993)
  • K924776 — BURTON LENSMETER - MODEL 2021 (April 5, 1993)
  • K924788 — BURTON LENSMETER (April 5, 1993)
  • K924780 — BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 (April 5, 1993)
  • K924784 — BURTON PROJECTOR HEAD - MODEL 6000-H (April 5, 1993)

Other clearances for product code HJB

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  • K864369 — LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER (December 15, 1986)
  • K864037 — KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER (November 13, 1986)
  • K852424 — ACUFEX COMPARATIVE SURGICAL KERATOMETER (September 11, 1985)