510(k) K133604

ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS by The Anspach Effort, Inc. — Product Code HBC

K133604 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS". The FDA issued a decision of Substantially Equivalent on January 10, 2014. The device falls under product code HBC (Motor, Drill, Electric), a Class II device regulated under 21 CFR 882.4360. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2014
Date Received
November 25, 2013
Clearance Type
Special
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