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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 K863961
Device Name HOSPAL BIOSPAL 1800S
Applicant
HOSPAL MEDICAL CORP.
25 KIMBERLY RD.
P.O. BOX 857
EAST BRUNSWICK,  NJ  08816
Applicant Contact CATHERINA MADORMO
Correspondent
HOSPAL MEDICAL CORP.
25 KIMBERLY RD.
P.O. BOX 857
EAST BRUNSWICK,  NJ  08816
Correspondent Contact CATHERINA MADORMO
Regulation Number876.5860
Classification Product Code
KDI  
Date Received10/10/1986
Decision Date 12/17/1986
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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