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510(k) K132264

PRIMADO2 TOTAL SURGICAL SYSTEM by Nakanishi, Inc. — Product Code HBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2013
Date Received
July 22, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Electric
Device Class
Class II
Regulation Number
882.4360
Review Panel
NE
Submission Type

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