510(k) K113476

ANSPACH DISSECTION TOOLS by The Anspach Effort, Inc. — Product Code HBE

K113476 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "ANSPACH DISSECTION TOOLS". The FDA issued a decision of Substantially Equivalent on December 16, 2011. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2011
Date Received
November 22, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device Class
Class II
Regulation Number
882.4310
Review Panel
NE
Submission Type