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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Upper Urinary Tract
510(k) Number K061918
Device Name FOLEY CATHETERS WITH TEMPERATURE PROBE
Applicant
Ge Healthcare
86 Pilgrim Rd.
Needham,  MA  02492
Applicant Contact JOEL KENT
Correspondent
Ge Healthcare
86 Pilgrim Rd.
Needham,  MA  02492
Correspondent Contact JOEL KENT
Regulation Number876.5130
Classification Product Code
EYC  
Date Received07/06/2006
Decision Date 08/18/2006
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
Predetermined Change
Control Plan Authorized		 No
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