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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Transducer, Dialysis
510(k) Number K072988
Device Name NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
Applicant
Nipro Medical Corporation
3150 NW 107th Ave.
Miami,  FL  33172
Applicant Contact JESSICA OSWALD
Correspondent
Nipro Medical Corporation
3150 NW 107th Ave.
Miami,  FL  33172
Correspondent Contact JESSICA OSWALD
Regulation Number876.5820
Classification Product Code
FIB  
Date Received10/23/2007
Decision Date 02/21/2008
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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