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510(k) K031305

OLYMPUS ULTRASONIC SURGICAL SYSTEM by Olympus Optical Co., Ltd. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2003
Date Received
April 24, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ultrasonic Surgical
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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  • K024138 — HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE (March 12, 2003)
  • K021852 — OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES (February 11, 2003)
  • K022445 — VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (January 24, 2003)
  • K024033 — XTJF-160AF DUODENOVIDEOSCOPE (December 20, 2002)
  • K023280 — OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES (December 19, 2002)
  • K013759 — MSS-28CS-301/701 NEEDLESCOPE (August 20, 2002)

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