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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 K030824
Device Name LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112
Applicant
Hakko Medical Co., Ltd.
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact ELIZABETH MILLER
Correspondent
Hakko Medical Co., Ltd.
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact ELIZABETH MILLER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/14/2003
Decision Date 06/04/2003
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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