FDA 510(k) Application Details - K042834

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K042834
Device Name Laparoscope, General & Plastic Surgery
Applicant MICROMEDICS, INC.
1270 EAGAN INDUSTRIAL ROAD
SUITE 120
ST PAUL, MN 55121 US
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Contact THOMAS A LOPAC
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 10/13/2004
Decision Date 02/11/2005
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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