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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 K983561
Device Name FUJINON EVL-F VIDEO LAPROSCOPE
Applicant
FUJINON, INC.
399 PARK AVE.
NEW YORK,  NY  10022 -4689
Applicant Contact GARY A ADLER
Correspondent
FUJINON, INC.
399 PARK AVE.
NEW YORK,  NY  10022 -4689
Correspondent Contact GARY A ADLER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/13/1998
Decision Date 12/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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