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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 K930817
Device Name LAPAROSCOPIC LYMPHADENECTOMY
Applicant
Fujinon, Inc.
399 Park Ave.
New York,  NY  10022
Applicant Contact FREDERIC ROSE
Correspondent
Fujinon, Inc.
399 Park Ave.
New York,  NY  10022
Correspondent Contact FREDERIC ROSE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/17/1993
Decision Date 07/28/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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