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FDA 510(k) Application Details - K142777
Device Classification Name
Clip, Implantable
More FDA Info for this Device
510(K) Number
K142777
Device Name
Clip, Implantable
Applicant
Teleflex Medical, Inc.
2917 Weck Drive
Research Triangle Park, NC 27709 US
Other 510(k) Applications for this Company
Contact
Ashlea Ricci
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
09/26/2014
Decision Date
12/19/2014
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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