FDA 510(k) Application Details - K964672

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K964672
Device Name Laparoscope, General & Plastic Surgery
Applicant LAURUS MEDICAL GROUP
10 CHRYSLER SUITE B
IRVINE, CA 92618 US
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Contact RICHARD A BASLER
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 11/21/1996
Decision Date 02/07/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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