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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Feeding
510(k) Number K131590
Device Name INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE
Applicant
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact CHRISTINE TREFETHEN
Correspondent
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact CHRISTINE TREFETHEN
Regulation Number876.5980
Classification Product Code
FPD  
Date Received05/31/2013
Decision Date 10/23/2013
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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