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510(k) K121338

ZEOBI by Ivivi Health Science, LLC — Product Code ILX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2012
Date Received
May 3, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5290
Review Panel
PM
Submission Type

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