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FDA 510(k) Application Details - K093661
Device Classification Name
Clip, Implantable
More FDA Info for this Device
510(K) Number
K093661
Device Name
Clip, Implantable
Applicant
NITI SURGICAL SOLUTIONS LTD
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20004 US
Other 510(k) Applications for this Company
Contact
JONATHAN KAHAN
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
11/25/2009
Decision Date
02/10/2011
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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