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510(k) K112188

PIEZOTOME SOLO by Satelec - Acteon, Inc. — Product Code DZI

K112188 is an FDA 510(k) premarket notification submitted by Satelec - Acteon, Inc. for the device "PIEZOTOME SOLO". The FDA issued a decision of Substantially Equivalent on February 3, 2012. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2012
Date Received
July 29, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Bone, Powered
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

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FDA data resources