510(k) K083112

PRIMADO by Nakanishi, Inc. — Product Code HBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2009
Date Received
October 21, 2008
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