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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 K895281
Device Name TRANSDUCER PROTECTOR
Applicant
Filtertek, Inc.
P.O. Box 310 Price Rd.
Hebron,  IL  60034
Applicant Contact LARRY LARKIN
Correspondent
Filtertek, Inc.
P.O. Box 310 Price Rd.
Hebron,  IL  60034
Correspondent Contact LARRY LARKIN
Regulation Number876.5820
Classification Product Code
FIB  
Date Received08/24/1989
Decision Date 11/08/1989
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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