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510(k) K070313

MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM by Misonix, Inc. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2007
Date Received
February 1, 2007
Clearance Type
Special
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

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  • K070779 — SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM (July 9, 2008)
  • K062471 — ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF (October 26, 2006)
  • K042096 — MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM (January 26, 2006)
  • K052702 — MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY (November 21, 2005)
  • K050776 — AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM (June 6, 2005)

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