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FDA 510(k) Application Details - K960317
Device Classification Name
Kit, Needle, Biopsy
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510(K) Number
K960317
Device Name
Kit, Needle, Biopsy
Applicant
LAURUS MEDICAL CORP.
30 HUGHES
SUITE 202
IRVINE, CA 92718 US
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Contact
NORMAN S GORDON
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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
01/23/1996
Decision Date
03/15/1996
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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