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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic access overtube, gastroenterology-urology
510(k) Number K022686
Device Name LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE
Applicant
LAP SURGICAL SYSTEMS, LLC
100 NORTH PENNSYLVANIA
ROSWELL,  NM  88203
Applicant Contact DONALD WENNER
Correspondent
LAP SURGICAL SYSTEMS, LLC
100 NORTH PENNSYLVANIA
ROSWELL,  NM  88203
Correspondent Contact DONALD WENNER
Regulation Number876.1500
Classification Product Code
FED  
Subsequent Product Codes
FBN   GCJ  
Date Received08/13/2002
Decision Date 11/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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