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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K072024
Device Name NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693
Applicant
NIPRO MEDICAL CORP.
3150 NW 107 AVE..
MIAMI,  FL  33172
Applicant Contact JESSICA OSWALD
Correspondent
NIPRO MEDICAL CORP.
3150 NW 107 AVE..
MIAMI,  FL  33172
Correspondent Contact JESSICA OSWALD
Regulation Number876.5820
Classification Product Code
FJK  
Date Received07/24/2007
Decision Date 10/04/2007
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
Recalls CDRH Recalls
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