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510(k) K962952

OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) by Olympus Optical, Co. — Product Code LBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1996
Date Received
July 30, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Ultrasonic Instruments
Device Class
Class U
Regulation Number
Review Panel
NE
Submission Type

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Other clearances for product code LBK

  • K972612 — DISSECTRON PORTABLE UNIT (October 8, 1997)
  • K884412 — CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA. (December 2, 1988)
  • K884413 — CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR (December 2, 1988)
  • K883522 — AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT (September 30, 1988)
  • K855138 — BOVIE ULTRASONIC SURGICAL SYSTEM (November 10, 1986)
  • K853143 — COOPER LASER SONICS CUSA MODEL 200 (October 16, 1985)