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510(k) K972612

DISSECTRON PORTABLE UNIT by Satelec — Product Code LBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1997
Date Received
July 14, 1997
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

  • K962952 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) (November 29, 1996)
  • 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)