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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 K851380
Device Name DISSCAP 110 DIALYZER
Applicant
HOSPAL MEDICAL CORP.
25 KIMBERLY RD.
P.O. BOX 857
EAST BRUNSWICK,  NJ  08816
Applicant Contact DOUGLAS S VLCHEK
Correspondent
HOSPAL MEDICAL CORP.
25 KIMBERLY RD.
P.O. BOX 857
EAST BRUNSWICK,  NJ  08816
Correspondent Contact DOUGLAS S VLCHEK
Regulation Number876.5820
Classification Product Code
FJI  
Date Received04/08/1985
Decision Date 04/25/1985
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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