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510(k) K042160

SONOSURG TROCAR by Aomori Olympus Co., Ltd. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2005
Date Received
August 10, 2004
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

Other clearances by Aomori Olympus Co., Ltd.

  • K041566 — SONOSURG ULTRASONIC SURGICAL SYSTEM (September 8, 2004)
  • K033333 — SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B (November 14, 2003)
  • K031523 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (October 1, 2003)
  • K031710 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (August 29, 2003)
  • K021672 — PANCREATIC DRAINAGE TUBE (April 16, 2003)
  • K022446 — MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C (March 28, 2003)

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