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510(k) K202788

Sonomed IV, Sonomed V by Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2021
Date Received
September 22, 2020
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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