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510(k) K843812

WOODLYN CLASSIC CATARACT ACUITY TEST by Woodlyn, Inc. — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1984
Date Received
September 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
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)
  • K841767 — WOODLYN CLASSIC KERATOMETER (August 7, 1984)
  • K841764 — WOODLYN CLASSIC JAVAL OPHTHALMOMETER (August 7, 1984)
  • K841761 — WOODLYN CLASSIC SLIT LAMP HSSL-CL (August 7, 1984)

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