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510(k) K180650

Amsel Endo Occluder by Amsel Medical Corporation — Product Code FZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2018
Date Received
March 13, 2018
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

Other clearances by Amsel Medical Corporation

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