DISSCAP 110 DIALYZER

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 110 Dialyzer.

Pre-market Notification Details

Device IDK851380
510k NumberK851380
Device Name:DISSCAP 110 DIALYZER
ClassificationDialyzer, Capillary, Hollow Fiber
Applicant HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick,  NJ  08816
ContactDouglas S Vlchek
CorrespondentDouglas S Vlchek
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 Received1985-04-08
Decision Date1985-04-25

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