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FDA 510(k) Application Details - K160521
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K160521
Device Name
Staple, Implantable
Applicant
ETHICON ENDO-SURGERY, LLC
475 CALLE C
GUAYNABO, PR 00969 US
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Contact
Marjorie Medina
Other 510(k) Applications for this Contact
Regulation Number
878.4750
More FDA Info for this Regulation Number
Classification Product Code
GDW
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More FDA Info for this Product Code
Date Received
02/25/2016
Decision Date
03/22/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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