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510(k) K983199

FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL by Fibra Sonics, Inc. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1998
Date Received
September 14, 1998
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 Fibra Sonics, Inc.

  • K993046 — FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 (November 22, 1999)
  • K984199 — EXONIX (February 17, 1999)
  • K984143 — FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM (February 16, 1999)
  • 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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