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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 K851428
Device Name TRANDUCER PROTECTOR
Applicant
GALVIN INDUSTRIES, INC.
828 WEST 24TH ST.
TEMPE,  AZ  85282
Applicant Contact JAY M GALVIN
Correspondent
GALVIN INDUSTRIES, INC.
828 WEST 24TH ST.
TEMPE,  AZ  85282
Correspondent Contact JAY M GALVIN
Regulation Number876.5820
Classification Product Code
FIB  
Date Received04/10/1985
Decision Date 05/21/1985
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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