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510(k) K112520

US-101L, US-103S by Ito Co., Ltd. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2011
Date Received
August 31, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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