510(k) K002903

ANSPACH ANGLED MICRONOSE ATTACHMENT by The Anspach Effort, Inc. — Product Code HBE

K002903 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "ANSPACH ANGLED MICRONOSE ATTACHMENT". The FDA issued a decision of Substantially Equivalent on October 24, 2000. 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
October 24, 2000
Date Received
September 18, 2000
Clearance Type
Traditional
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