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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 K941563
Device Name THE BIOPSY TOOL
Applicant
CITATION MEDICAL CORP.
230 EDISON WAY
RENO,  NV  89502
Applicant Contact EDWARD F WADDELL
Correspondent
CITATION MEDICAL CORP.
230 EDISON WAY
RENO,  NV  89502
Correspondent Contact EDWARD F WADDELL
Regulation Number876.1075
Classification Product Code
FCG  
Date Received04/01/1994
Decision Date 09/26/1994
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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