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510(k) K130888

SONOPULSE/ SONOPULSE III by Ibramed- Industria Brazileria DE Equipamentos Medi — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2014
Date Received
March 29, 2013
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

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