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510(k) K121059

SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM by Zimmer Medizinsystems GmbH — Product Code IMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2012
Date Received
April 6, 2012
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5860
Review Panel
PM
Submission Type

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