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FDA 510(k) Application Details - K111930
Device Classification Name
Clip, Implantable
More FDA Info for this Device
510(K) Number
K111930
Device Name
Clip, Implantable
Applicant
ACKERMANN INSTRUMENTE GMBH
8202 SHERMAN ROAD
CHESTERLAND, OH 44026-2141 US
Other 510(k) Applications for this Company
Contact
KAREN E WARDEN, PHD
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
07/07/2011
Decision Date
11/08/2011
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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