FDA 510(k) Application Details - K041751

Device Classification Name Clip, Implantable

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510(K) Number K041751
Device Name Clip, Implantable
Applicant NITI MEDICAL TECHNOLOGIES LTD.
1 HATZORAN ST.
P.O. BOX 8634
NETANYA 42506 IL
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Contact ORLY MAOR
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 06/29/2004
Decision Date 09/16/2004
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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