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510(k) K993628

OMNISONICS ULTRASONIC PROBES by Omnisonics Medical Technologies — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1999
Date Received
October 27, 1999
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 Omnisonics Medical Technologies

  • K083335 — MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM (December 15, 2008)
  • K071762 — OMNIWAVE ENDOVASCULAR SYSTEM (September 27, 2007)
  • K052428 — RESOLUTION ENDOVASCULAR SYSTEM (December 8, 2005)
  • K041705 — RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 (September 1, 2004)
  • K003824 — OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI (March 8, 2001)
  • K993445 — OMNISONIC ENDOSCOPIC DEFLECTOR (December 6, 1999)
  • K991377 — OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER (July 12, 1999)

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