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FDA 510(k) Application Details - K983218
Device Classification Name
Kit, Needle, Biopsy
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510(K) Number
K983218
Device Name
Kit, Needle, Biopsy
Applicant
AVID N.I.T., INC.
390 SCARLET BLVD.
OLDSMAR, FL 34677 US
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Contact
JOSEPH E HARMS
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Regulation Number
876.1075
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Classification Product Code
FCG
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More FDA Info for this Product Code
Date Received
09/14/1998
Decision Date
11/06/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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