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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 K990731
Device Name EASTGATE PERSONAL MONITOR
Applicant
Eastgate Trading Corp.
990 Ave. Of Americas, #15d
New York,  NY  10084
Applicant Contact MORRIS CORN
Correspondent
Eastgate Trading Corp.
990 Ave. Of Americas, #15d
New York,  NY  10084
Correspondent Contact MORRIS CORN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/05/1999
Decision Date 05/19/1999
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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