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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K012977
Device Name VARICES INJECTION NEEDLE
Applicant
Endo-Therapeutics, Inc.
1183 Cedar St.
Safety Harbor,  FL  34695 -2908
Applicant Contact TODD ADKISSON
Correspondent
Endo-Therapeutics, Inc.
1183 Cedar St.
Safety Harbor,  FL  34695 -2908
Correspondent Contact TODD ADKISSON
Regulation Number876.1500
Classification Product Code
FBK  
Date Received09/05/2001
Decision Date 11/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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