COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER

Apparatus, Autotransfusion

COBE LABORATORIES, INC.

The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Autologous Blood Salvage Reserv W/w/o Filter.

Pre-market Notification Details

Device IDK902671
510k NumberK902671
Device Name:COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER
ClassificationApparatus, Autotransfusion
Applicant COBE LABORATORIES, INC. 14401 WEST 56TH WAY Arvada,  CO  80004
ContactMary L Armstrong
CorrespondentMary L Armstrong
COBE LABORATORIES, INC. 14401 WEST 56TH WAY Arvada,  CO  80004
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-18
Decision Date1990-07-17

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