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510(k) K984199

EXONIX by Fibra Sonics, Inc. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1999
Date Received
November 24, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
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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