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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 K895856
Device Name MEDISYSTEMS TRANSDUCER PROTECTOR
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 Number876.5820
Classification Product Code
FIB  
Date Received10/02/1989
Decision Date 11/24/1989
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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