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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 K041751
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 Received06/29/2004
Decision Date 09/16/2004
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
Predetermined Change
Control Plan Authorized		 No
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