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510(k) K093361

SYNTHES AIR PEN DRIVE (APD) SYSTEM by Synthes (Usa) — Product Code HBB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2010
Date Received
October 28, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Pneumatic
Device Class
Class II
Regulation Number
882.4370
Review Panel
NE
Submission Type

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