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510(k) K841768

WOODLYN LIGHTWEIGHT TRIAL FRAME by Woodlyn, Inc. — Product Code HPA

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
Frame, Trial, Ophthalmic
Device Class
Class I
Regulation Number
886.1415
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)
  • K841767 — WOODLYN CLASSIC KERATOMETER (August 7, 1984)
  • K841764 — WOODLYN CLASSIC JAVAL OPHTHALMOMETER (August 7, 1984)

Other clearances for product code HPA

  • K852548 — ATL 225 MW TRAIL LENS SET (July 31, 1985)
  • K852126 — ATF 101 TRAIL FRAME (June 5, 1985)
  • K833669 — IMAGE DEFLECTOR (March 27, 1984)
  • K821084 — UNIVERSAL TRIAL FRAMEE (June 14, 1982)