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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 K010264
Device Name NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
Applicant
Nipro Medical Corp.
510 Stonemont Dr.
Weston,  FL  33326
Applicant Contact RICHARD D BLISS, JR
Correspondent
Nipro Medical Corp.
510 Stonemont Dr.
Weston,  FL  33326
Correspondent Contact RICHARD D BLISS, JR
Regulation Number876.5820
Classification Product Code
FIB  
Subsequent Product Code
FJK  
Date Received01/29/2001
Decision Date 04/27/2001
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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