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510(k) K993046

FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 by Fibra Sonics, Inc. — Product Code FEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1999
Date Received
September 10, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Ultrasonic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type

Other clearances by Fibra Sonics, Inc.

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  • K983199 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL (December 14, 1998)
  • K980930 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA (September 22, 1998)
  • K842024 — ULTRASONIC LITHOTRIPTOR 300A (December 11, 1984)
  • K834453 — PHACO FRAGMENTOR GT-1 (March 16, 1984)
  • K813389 — ULTRASONIC FRAGMENTOR (February 4, 1982)
  • K812909 — HYGIENTIST; CYCLOSON I & II; RETROFIT (December 14, 1981)
  • K802381 — LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. (December 17, 1980)

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  • K873367 — OLYMPUS LUS ULTRASONIC LITHOTRIPTER (November 30, 1987)