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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 K915593
Device Name TRANSDUCER PROTECTOR
Applicant
UNITED PHARMACEUTICAL AND MEDICAL SUPPLY CO.
2921 TELEGRAPH AVE.
BERKELEY,  CA  94705
Applicant Contact THOMAS CANE
Correspondent
UNITED PHARMACEUTICAL AND MEDICAL SUPPLY CO.
2921 TELEGRAPH AVE.
BERKELEY,  CA  94705
Correspondent Contact THOMAS CANE
Regulation Number876.5820
Classification Product Code
FIB  
Date Received12/13/1991
Decision Date 07/01/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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