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510(k) K841759

OPHTHALMIC TABLE by Woodlyn, Inc. — Product Code HMG

K841759 is an FDA 510(k) premarket notification submitted by Woodlyn, Inc. for the device "OPHTHALMIC TABLE". The FDA issued a decision of Substantially Equivalent on June 1, 1984. The device falls under product code HMG (Stand, Instrument, Ophthalmic, Non-Powered), a Class I device regulated under 21 CFR 886.1860. Woodlyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1984
Date Received
April 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stand, Instrument, Ophthalmic, Non-Powered
Device Class
Class I
Regulation Number
886.1860
Review Panel
OP
Submission Type

Other clearances by Woodlyn, Inc.

  • K931303 — WOODLYN OPERATION MICROSCOPE (June 25, 1993)
  • K920861 — WOODLYN CLASSIC LENSMETER (July 30, 1992)
  • K900476 — WOODLYN SLIT LAMP MODEL HR-1 (February 21, 1990)
  • K900478 — WOODLYN FULL APERTURE TRIAL LENS SET (February 21, 1990)
  • K900477 — WOODLYN CLASSIC SLIT LAMP MODEL SMM (February 21, 1990)
  • K890992 — WOODLYN OPHTHALMIC PROJECTOR (May 17, 1989)
  • K874900 — WOODLYN CLASSIC REFRACTOR, PHOROPTOR (December 23, 1987)
  • K843812 — WOODLYN CLASSIC CATARACT ACUITY TEST (December 11, 1984)
  • K841765 — WOODLYN STANDARD SLIT LAMP HSSL-ST (August 7, 1984)
  • K841764 — WOODLYN CLASSIC JAVAL OPHTHALMOMETER (August 7, 1984)

Other clearances for product code HMG

  • K900161 — A-SCAN ROLL-AROUND STAND (February 16, 1990)
  • K883575 — MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE (September 12, 1988)
  • K873554 — GORSK INSTRUMENT REST (October 23, 1987)

FDA data resources