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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Fistula
510(k) Number K910734
Device Name MEDISYSTEMS HEMODIALYSIS FISTULA SET
Applicant
Medisystems Corp.
21st Floor
345 California St.
San Francisco,  CA  94104
Applicant Contact ALAN C HINTON
Correspondent
Medisystems Corp.
21st Floor
345 California St.
San Francisco,  CA  94104
Correspondent Contact ALAN C HINTON
Regulation Number876.5540
Classification Product Code
FIE  
Subsequent Product Code
FMI  
Date Received02/21/1991
Decision Date 06/20/1991
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
Recalls CDRH Recalls
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