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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, Capillary, Hollow Fiber
510(k) Number K950602
Device Name PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS
Applicant
Reprocessing Products Corp
2730 E. Broadway Blvd.
Suite 135 P.O. Box 40970
Tucson,  AZ  85716
Applicant Contact MICHAEL HONSTEIN
Correspondent
Reprocessing Products Corp
2730 E. Broadway Blvd.
Suite 135 P.O. Box 40970
Tucson,  AZ  85716
Correspondent Contact MICHAEL HONSTEIN
Regulation Number876.5820
Classification Product Code
FJI  
Date Received02/09/1995
Decision Date 11/30/1995
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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