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510(k) K924786

BURTON TRIAL LENS SET by R.H. Burton Co. — Product Code HPC

K924786 is an FDA 510(k) premarket notification submitted by R.H. Burton Co. for the device "BURTON TRIAL LENS SET". The FDA issued a decision of Substantially Equivalent on April 14, 1993. The device falls under product code HPC (Set, Lens, Trial, Ophthalmic), a Class I device regulated under 21 CFR 886.1405. R.H. Burton Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1993
Date Received
September 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Lens, Trial, Ophthalmic
Device Class
Class I
Regulation Number
886.1405
Review Panel
OP
Submission Type

Other clearances by R.H. Burton Co.

  • K924773 — BURTON H- BASE TABLE - MODEL 1990 (June 7, 1993)
  • K924783 — BURTON SLIT LAMP - MODEL 850 (April 14, 1993)
  • K924774 — BURTON AUTOMATIC PROJECTOR - MODEL CP-40 (April 14, 1993)
  • K924790 — BURTON AUTO REFRACTOR - MODEL BAR-7 (April 5, 1993)
  • K924788 — BURTON LENSMETER (April 5, 1993)
  • K924780 — BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 (April 5, 1993)
  • K924778 — BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 (April 5, 1993)
  • K924776 — BURTON LENSMETER - MODEL 2021 (April 5, 1993)
  • K924785 — BURTON RADIUSGAUGE - MODEL 2030 (April 5, 1993)
  • K924777 — BURTON APPLANATION TONOMETER - MODEL T850 & T1000 (April 5, 1993)

Other clearances for product code HPC

  • K945443 — BOBES LENS SET (July 19, 1995)
  • K951437 — OTI MODEL TLS-60 (April 11, 1995)
  • K930195 — OPHTHALMIC TRIAL LENSES (January 6, 1994)
  • K934859 — CONTACT LENSES (December 21, 1993)
  • K930446 — MARCO TRIAL SETS (July 6, 1993)
  • K920571 — TRIAL LENS SET (May 7, 1992)
  • K900478 — WOODLYN FULL APERTURE TRIAL LENS SET (February 21, 1990)
  • K873907 — CONFIRMATION TESTS (December 29, 1987)
  • K852056 — ACC CROSS CYLINDERS (June 5, 1985)
  • K843095 — TRIA LENS SET (October 5, 1984)

FDA data resources