DISSCAP 80E, 110E, 140E, 160E

Dialyzer, Capillary, Hollow Fiber

HOSPAL MEDICAL CORP.

The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Disscap 80e, 110e, 140e, 160e.

Pre-market Notification Details

Device IDK863592
510k NumberK863592
Device Name:DISSCAP 80E, 110E, 140E, 160E
ClassificationDialyzer, Capillary, Hollow Fiber
Applicant HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick,  NJ  08816
ContactCatherina Madormo
CorrespondentCatherina Madormo
HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick,  NJ  08816
Product CodeFJI  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-15
Decision Date1986-09-25

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