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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 K954519
Device Name WANG TRANSENDOSCOPIC ASPIRATION NEEDLE
Applicant
MILL-ROSE LABORATORY
7310 CORPORATE BLVD.
MENTOR,  OH  44060 -4885
Applicant Contact ALAN C POJE
Correspondent
MILL-ROSE LABORATORY
7310 CORPORATE BLVD.
MENTOR,  OH  44060 -4885
Correspondent Contact ALAN C POJE
Regulation Number876.1500
Classification Product Code
FBK  
Date Received09/28/1995
Decision Date 12/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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