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510(k) K163308

SMARTO by Jeil Medical Corporation — Product Code KIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2016
Date Received
November 23, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

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