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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 K031238
Device Name VARICES NEEDLE
Applicant
Scandimed. A.S.
280 Godshall Rd.
Collegeville,  PA  19426
Applicant Contact COURTNEY SMITH
Correspondent
Scandimed. A.S.
280 Godshall Rd.
Collegeville,  PA  19426
Correspondent Contact COURTNEY SMITH
Regulation Number876.1500
Classification Product Code
FBK  
Date Received04/18/2003
Decision Date 10/04/2004
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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