HEMOSPAL KITS A1, A2D, AO, & A1D

Dialyzer, Parallel Flow

GAMBRO-HOSPAL, INC.

The following data is part of a premarket notification filed by Gambro-hospal, Inc. with the FDA for Hemospal Kits A1, A2d, Ao, & A1d.

Pre-market Notification Details

Device IDK901368
510k NumberK901368
Device Name:HEMOSPAL KITS A1, A2D, AO, & A1D
ClassificationDialyzer, Parallel Flow
Applicant GAMBRO-HOSPAL, INC. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg,  VA  23185
ContactJeffrey Shideman,phd
CorrespondentJeffrey Shideman,phd
GAMBRO-HOSPAL, INC. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg,  VA  23185
Product CodeFJG  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-23
Decision Date1990-08-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.