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FDA 510(k) Application Details - K150840
Device Classification Name
Clip, Implantable
More FDA Info for this Device
510(K) Number
K150840
Device Name
Clip, Implantable
Applicant
ETHICON ENDO-SURGERY, LLC
475 CALLE C SUITE 202
GUAYNABO, PR 00969 US
Other 510(k) Applications for this Company
Contact
Marjorie Medina
Other 510(k) Applications for this Contact
Regulation Number
878.4300
More FDA Info for this Regulation Number
Classification Product Code
FZP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/30/2015
Decision Date
09/10/2015
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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