BSM 21 BLOOD SAFETY MODULE

Accessories, Blood Circuit, Hemodialysis

HOSPAL MEDICAL CORP.

The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Bsm 21 Blood Safety Module.

Pre-market Notification Details

Device IDK852135
510k NumberK852135
Device Name:BSM 21 BLOOD SAFETY MODULE
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick,  NJ  08816
ContactFressinet
CorrespondentFressinet
HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick,  NJ  08816
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-16
Decision Date1985-06-12

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