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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 K910821
Device Name TRANSDUCER PROTECTOR
Applicant
GELMAN SCIENCES, INC.
600 SOUTH WAGNER RD.
ANN ARBOR,  MI  48103 -9019
Applicant Contact HARWOOD GREEN
Correspondent
GELMAN SCIENCES, INC.
600 SOUTH WAGNER RD.
ANN ARBOR,  MI  48103 -9019
Correspondent Contact HARWOOD GREEN
Regulation Number876.5820
Classification Product Code
FIB  
Date Received02/26/1991
Decision Date 08/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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