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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K090792
Device Name MITAKA UNIARM
Applicant
Mitaka Kohki Co., Ltd.
2337 Lucky John Dr.
Park City,  UT  84060
Applicant Contact MAXWELL STURGIS
Correspondent
Mitaka Kohki Co., Ltd.
2337 Lucky John Dr.
Park City,  UT  84060
Correspondent Contact MAXWELL STURGIS
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
GWG  
Date Received03/24/2009
Decision Date 07/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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