FDA 510(k) Application Details - K041967

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K041967
Device Name Laparoscope, General & Plastic Surgery
Applicant GENICON
427 LAKE HOWELL
MAITLAND, FL 32751 US
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Contact GARY HABERLAND
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 07/21/2004
Decision Date 11/12/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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