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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 K000702
Device Name BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
Applicant
Fresenius Medical Care North America
Two Ledgemont Center
95 Hayden Ave.
Lexington,  MA  02420
Applicant Contact ARTHUR EILINSFELD
Correspondent
Fresenius Medical Care North America
Two Ledgemont Center
95 Hayden Ave.
Lexington,  MA  02420
Correspondent Contact ARTHUR EILINSFELD
Regulation Number876.5820
Classification Product Code
FIB  
Subsequent Product Code
FJK  
Date Received03/01/2000
Decision Date 06/07/2000
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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