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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 K983076
Device Name MEDISYSTEMS TRANSDUCER PROTECTOR
Applicant
Medisystems Corp.
1900 K St. NW
Washington,  DC  20006
Applicant Contact LARRY R PILOT
Correspondent
Medisystems Corp.
1900 K St. NW
Washington,  DC  20006
Correspondent Contact LARRY R PILOT
Regulation Number876.5820
Classification Product Code
FIB  
Date Received09/02/1998
Decision Date 11/25/1998
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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