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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K781464
Device Name HEMODIALYZER, MODEL RP610, RP AN 69
Applicant
HOSPAL MEDICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HOSPAL MEDICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/25/1978
Decision Date 12/20/1978
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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