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FDA 510(k) Application Details - K040604
Device Classification Name
Laparoscope, General & Plastic Surgery
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510(K) Number
K040604
Device Name
Laparoscope, General & Plastic Surgery
Applicant
ARTHROTEK, INC.
56 EAST BELLE DR.
P.O. BOX 587
WARSAW, IN 46582 US
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Contact
KACY ARNOLD
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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
03/08/2004
Decision Date
06/04/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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