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510(k) K873907

CONFIRMATION TESTS by Richmond Products, Inc. — Product Code HPC

K873907 is an FDA 510(k) premarket notification submitted by Richmond Products, Inc. for the device "CONFIRMATION TESTS". The FDA issued a decision of Substantially Equivalent on December 29, 1987. The device falls under product code HPC (Set, Lens, Trial, Ophthalmic), a Class I device regulated under 21 CFR 886.1405. Richmond Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1987
Date Received
September 25, 1987
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 Richmond Products, Inc.

  • K874252 — KREDA DISC (January 27, 1988)
  • K874251 — WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT (January 11, 1988)
  • K874250 — THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT. (January 11, 1988)
  • K873908 — H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. (December 23, 1987)
  • K873916 — 'E' CUBE AND 'E' PAD (December 11, 1987)
  • K873914 — ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) (December 11, 1987)
  • K873913 — COLOR BOOK ILLUMINATOR STAND (December 2, 1987)
  • K873911 — PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 (December 2, 1987)
  • K873917 — TONOMETER TAPES (November 2, 1987)
  • K873912 — RICHMOND VISUAL FIELD SCREENER (November 2, 1987)

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)
  • K920571 — TRIAL LENS SET (May 7, 1992)
  • K900478 — WOODLYN FULL APERTURE TRIAL LENS SET (February 21, 1990)
  • K852056 — ACC CROSS CYLINDERS (June 5, 1985)
  • K843095 — TRIA LENS SET (October 5, 1984)

FDA data resources