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510(k) K931303

WOODLYN OPERATION MICROSCOPE by Woodlyn, Inc. — Product Code FSO

K931303 is an FDA 510(k) premarket notification submitted by Woodlyn, Inc. for the device "WOODLYN OPERATION MICROSCOPE". The FDA issued a decision of Substantially Equivalent on June 25, 1993. The device falls under product code FSO (Microscope, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4700. Woodlyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1993
Date Received
March 15, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4700
Review Panel
SU
Submission Type

Other clearances by Woodlyn, Inc.

  • K920861 — WOODLYN CLASSIC LENSMETER (July 30, 1992)
  • K900476 — WOODLYN SLIT LAMP MODEL HR-1 (February 21, 1990)
  • K900477 — WOODLYN CLASSIC SLIT LAMP MODEL SMM (February 21, 1990)
  • K900478 — WOODLYN FULL APERTURE TRIAL LENS SET (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)
  • K841761 — WOODLYN CLASSIC SLIT LAMP HSSL-CL (August 7, 1984)
  • K841764 — WOODLYN CLASSIC JAVAL OPHTHALMOMETER (August 7, 1984)

Other clearances for product code FSO

  • K942304 — MICROFLEX (June 13, 1994)
  • K941399 — OPERATING MICROSCOPE AA OM 10 (April 22, 1994)
  • K920689 — DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM (November 12, 1993)
  • K926288 — SOM 6VI (SURGICAL OPERATING MICROSCOPE) (October 12, 1993)
  • K926513 — MOLLER-WEDEL OPERATING MICROSCOPE (June 22, 1993)
  • K910357 — SOM 6V (February 19, 1991)
  • K902076 — J2 MICROSCOPE (August 1, 1990)
  • K874241 — OPMI MD SURGICAL MICROSCOPE (December 23, 1987)
  • K822562 — ODONTO-SCOPE (October 6, 1982)
  • K822181 — BINOCULAR OPER. MICROSCOPES & ACCESSOR (August 27, 1982)

FDA data resources