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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscopic Single Port Access Device
510(k) Number K112196
Device Name OCTOTMPORT
Applicant
Dalim Surgnet Corporation
325 N. Puente St., Unit B
Brea,  CA  92821
Applicant Contact APRIL LEE
Correspondent
Dalim Surgnet Corporation
325 N. Puente St., Unit B
Brea,  CA  92821
Correspondent Contact APRIL LEE
Regulation Number876.1500
Classification Product Code
OTJ  
Date Received08/01/2011
Decision Date 09/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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