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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name biopsy needle
510(k) Number K954596
Device Name PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM
Applicant
PROMEDICAL LTD.
240 BRAEN AVE.
WYCKOFF,  NJ  07481
Applicant Contact HENRY V SIERAKOWSKI
Correspondent
PROMEDICAL LTD.
240 BRAEN AVE.
WYCKOFF,  NJ  07481
Correspondent Contact HENRY V SIERAKOWSKI
Regulation Number876.1075
Classification Product Code
FCG  
Date Received10/03/1995
Decision Date 10/07/1995
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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