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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 K020307
Device Name LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112
Applicant
Hakko Shoji Co., Ltd.
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact ELIZABETH MILLER
Correspondent
Hakko Shoji Co., Ltd.
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact ELIZABETH MILLER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/29/2002
Decision Date 04/26/2002
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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