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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 K870394
Device Name HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS
Applicant
Clinical Connections, Inc.
P.O. Box 238
9287 Smucker Rd.
Orrville,  OH  44667
Applicant Contact KEITH ANTAL
Correspondent
Clinical Connections, Inc.
P.O. Box 238
9287 Smucker Rd.
Orrville,  OH  44667
Correspondent Contact KEITH ANTAL
Regulation Number876.5820
Classification Product Code
FIB  
Date Received01/30/1987
Decision Date 03/03/1987
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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