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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Guidewire, Gastroenterology-Urology
510(k) Number K923755
Device Name FLEX FINDER GUIDEWIRE
Applicant
Flex Medics Corporation
12400 Whitewater Dr., Suite 2040
Minnetonka,  MN  55343
Applicant Contact DANIEL CORCORAN
Correspondent
Flex Medics Corporation
12400 Whitewater Dr., Suite 2040
Minnetonka,  MN  55343
Correspondent Contact Debra K. Fritz
Regulation Number876.1500
Classification Product Code
OCY  
Date Received07/24/1992
Decision Date 09/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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