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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 K983218
Device Name N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE
Applicant
AVID N.I.T., INC.
390 SCARLET BLVD.
OLDSMAR,  FL  34677
Applicant Contact JOSEPH E HARMS
Correspondent
AVID N.I.T., INC.
390 SCARLET BLVD.
OLDSMAR,  FL  34677
Correspondent Contact JOSEPH E HARMS
Regulation Number876.1075
Classification Product Code
FCG  
Date Received09/14/1998
Decision Date 11/06/1998
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
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