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510(k) K112599

INSURGICAL SINGLE USE POWER EQUIPMENT by Insurgical, LLC — Product Code KIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2012
Date Received
September 7, 2011
Clearance Type
Traditional
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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