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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Television, Endoscopic, Without Audio
510(k) Number K930297
Device Name FUJINON VIDEO LAPAROSCOPE, MODIFIED
Applicant
Fujinon, Inc.
399 Park Ave.
New York,  NY  10022 -4689
Applicant Contact FREDERIC B ROSE
Correspondent
Fujinon, Inc.
399 Park Ave.
New York,  NY  10022 -4689
Correspondent Contact FREDERIC B ROSE
Regulation Number878.4160
Classification Product Code
FWF  
Date Received01/21/1993
Decision Date 03/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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