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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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More FDA Info for this Product Code
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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