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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 K993135
Device Name IMPLANTABLE CLIP FOR GENERAL SURGERY
Applicant
Applied Medical Resources
26051 Merit Circle
Bldg. 104
Launa Hills,  CA  92653
Applicant Contact ANIL BHALANI
Correspondent
Applied Medical Resources
26051 Merit Circle
Bldg. 104
Launa Hills,  CA  92653
Correspondent Contact ANIL BHALANI
Regulation Number878.4300
Classification Product Code
FZP  
Date Received09/20/1999
Decision Date 12/01/1999
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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