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FDA 510(k) Application Details - K180650
Device Classification Name
Clip, Implantable
More FDA Info for this Device
510(K) Number
K180650
Device Name
Clip, Implantable
Applicant
Amsel Medical Corporation
171 Hamilton Street
Cambridge, MA 02139 US
Other 510(k) Applications for this Company
Contact
Yoram Levy
Other 510(k) Applications for this Contact
Regulation Number
878.4300
More FDA Info for this Regulation Number
Classification Product Code
FZP
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More FDA Info for this Product Code
Date Received
03/13/2018
Decision Date
11/15/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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