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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 K033024
Device Name MODIFICATION TO SUTURE CLINCH
Applicant
APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact CHERYL BLAKE
Correspondent
APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent Contact CHERYL BLAKE
Regulation Number878.4300
Classification Product Code
FZP  
Date Received09/26/2003
Decision Date 10/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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