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510(k) K920571

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

K920571 is an FDA 510(k) premarket notification submitted by R.H. Burton Co. for the device "TRIAL LENS SET". The FDA issued a decision of Substantially Equivalent on May 7, 1992. 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
May 7, 1992
Date Received
February 7, 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)
  • K924786 — BURTON TRIAL LENS SET (April 14, 1993)
  • K924774 — BURTON AUTOMATIC PROJECTOR - MODEL CP-40 (April 14, 1993)
  • K924784 — BURTON PROJECTOR HEAD - MODEL 6000-H (April 5, 1993)
  • K924776 — BURTON LENSMETER - MODEL 2021 (April 5, 1993)
  • K924788 — BURTON LENSMETER (April 5, 1993)
  • K924790 — BURTON AUTO REFRACTOR - MODEL BAR-7 (April 5, 1993)
  • K924778 — BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 (April 5, 1993)
  • K924771 — BURTON OPHTHALMIC STAND - MODEL XL3200 (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)
  • K924786 — BURTON TRIAL LENS SET (April 14, 1993)
  • 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