FDA 510(k) Application Details - K022686

Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology

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510(K) Number K022686
Device Name Endoscopic Access Overtube, Gastroenterology-Urology
Applicant LAP SURGICAL SYSTEMS, LLC
100 NORTH PENNSYLVANIA
ROSWELL, NM 88203 US
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Contact DONALD WENNER
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Regulation Number 876.1500

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Classification Product Code FED
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Date Received 08/13/2002
Decision Date 11/25/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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