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510(k) K161628

JAS Pulse(TM) Ultrasonic Therapy by Bonutti Research, Inc. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2016
Date Received
June 13, 2016
Clearance Type
Abbreviated
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 Bonutti Research, Inc.

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  • K060283 — TRANSET SYSTEM (February 22, 2006)
  • K052799 — MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM (December 16, 2005)
  • K033717 — TRANSET FRACTURE FIXATION SYSTEM (February 25, 2004)
  • K013177 — MULTITAK SUTURE SNAP SYSTEM (December 19, 2001)
  • K012465 — MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR (October 29, 2001)
  • K010479 — MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR (May 8, 2001)

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