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510(k) K162525

Oniko nail brace by Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti — Product Code MQZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 25, 2018
Date Received: September 9, 2016
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Prosthesis, Nail
Device Class: Class U
Regulation Number
Review Panel: SU
Submission Type