DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT

Apparatus, Autotransfusion

DAVOL, INC.

The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Davol Cardiovascular Autotransfusion Unit.

Pre-market Notification Details

Device IDK931552
510k NumberK931552
Device Name:DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT
ClassificationApparatus, Autotransfusion
Applicant DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston,  RI  02920
ContactRobin M Drago
CorrespondentRobin M Drago
DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston,  RI  02920
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-29
Decision Date1993-10-08

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