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510(k) K953965

904 SLIT LAMP by Clement Clarke, Inc. — Product Code HJO

K953965 is an FDA 510(k) premarket notification submitted by Clement Clarke, Inc. for the device "904 SLIT LAMP". The FDA issued a decision of Substantially Equivalent on September 27, 1995. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Clement Clarke, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1995
Date Received
August 22, 1995
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 Clement Clarke, Inc.

  • K961512 — PERKINS HAND-HELD APPLANATION TONOMETER (July 18, 1996)
  • K952713 — MINI WRIGHT LR AFS (March 29, 1996)
  • K932258 — OPTICOM M600 (July 25, 1994)
  • K914126 — VMX MINI-LOG FLOWMETER (March 5, 1993)
  • K914896 — FRIEDMANN ANALYSER 3 (January 23, 1992)
  • K912397 — PROFESSIONAL INDIRECT OPHTHALMOSCOPE (October 23, 1991)
  • K895953 — WRIGHT VENTILOMETER VM-1 (February 2, 1990)
  • K841430 — LASERSPEC (December 13, 1984)
  • K781313 — VISION-STIMULATOR, CAM (January 26, 1979)

Other clearances for product code HJO

  • K253834 — VISUREF 600 (March 18, 2026)
  • K231760 — HP-OCT (HP-OCT) (March 8, 2024)
  • K222372 — Kowa SL-19 (November 21, 2022)
  • K193188 — MiiS Horus Eye Anterior Camera (January 14, 2020)
  • K182306 — Sunkingdom Slit Lamp (November 22, 2018)
  • K173771 — IOLMaster 700 (August 24, 2018)
  • K171877 — SLM-1ER, SLM-2ER, SLM-3ER (December 21, 2017)
  • K170470 — Digital Eye Anterior Camera (October 6, 2017)
  • K162778 — Portable Slit Lamp Microscope (July 21, 2017)
  • K162684 — SL 220 (May 31, 2017)

FDA data resources