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FDA 510(k) Application Details - K982944
Device Classification Name
Clip, Implantable
More FDA Info for this Device
510(K) Number
K982944
Device Name
Clip, Implantable
Applicant
WECK CLOSURE SYSTEMS
ONE WECK DR.
RESEARCH TRIANGLE PARK, NC 27709 US
Other 510(k) Applications for this Company
Contact
BRIAN J YOUNG
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
08/21/1998
Decision Date
11/19/1998
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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