SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM

Apparatus, Autotransfusion

SOLCO BASLE, INC.

The following data is part of a premarket notification filed by Solco Basle, Inc. with the FDA for Solcotrans Chest Drainage Autotransfusion System.

Pre-market Notification Details

Device IDK872590
510k NumberK872590
Device Name:SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM
ClassificationApparatus, Autotransfusion
Applicant SOLCO BASLE, INC. 169 WEYMOUTH ST. Rockland,  MA  02370
ContactRosanne Terraciano
CorrespondentRosanne Terraciano
SOLCO BASLE, INC. 169 WEYMOUTH ST. Rockland,  MA  02370
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-01
Decision Date1987-09-04

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