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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, gastrointestinal motility (electrical)
510(k) Number K160170
Device Name Lehman Manometry Catheter
Applicant
Wilson-Cook Medical, Inc.
4900 Bethania Station Road
Winston-Salem,  NC  27105
Applicant Contact Doris A. Hawks
Correspondent
Wilson-Cook Medical, Inc.
4900 Bethania Station Road
Winston-Salem,  NC  27105
Correspondent Contact Doris A. Hawks
Regulation Number876.1725
Classification Product Code
FFX  
Date Received01/27/2016
Decision Date 06/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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