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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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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