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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 K983527
Device Name MICROENDOSCOPE, MINIATURIZED BIOPSY SCOPE
Applicant
Dofi Technologies, Inc.
150 W. 51st St., #1108
New York,  NY  10019
Applicant Contact TONY ANTHONY
Correspondent
Dofi Technologies, Inc.
150 W. 51st St., #1108
New York,  NY  10019
Correspondent Contact TONY ANTHONY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/08/1998
Decision Date 01/19/1999
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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