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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, implantable
510(k) Number K033324
Device Name COMPRESSION ANASTOMOSIS CLIP (CAC)
Applicant
NITI MEDICAL TECHNOLOGIES LTD.
1 HATZORAN ST.
P.O. BOX 8634
NETANYA,  IL 42506
Applicant Contact ORLY MAOR
Correspondent
NITI MEDICAL TECHNOLOGIES LTD.
1 HATZORAN ST.
P.O. BOX 8634
NETANYA,  IL 42506
Correspondent Contact ORLY MAOR
Regulation Number878.4300
Classification Product Code
FZP  
Date Received10/15/2003
Decision Date 05/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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