FDA 510(k) Application Details - K041641

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K041641
Device Name Laparoscope, General & Plastic Surgery
Applicant C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON, RI 02920 US
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Contact SUZANNE LASCALZA
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 06/17/2004
Decision Date 07/01/2004
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 Y
Expedited Review



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