510(k) K140932

AMSEL OCCLUDER DEVICE by Amsel Medical Corporation — Product Code FZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2015
Date Received
April 11, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type