PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM

Apparatus, Autotransfusion

DEKNATEL, INC.

The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Pleur-evac(r)-a-7020-infant Chest Drain System.

Pre-market Notification Details

Device IDK883082
510k NumberK883082
Device Name:PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM
ClassificationApparatus, Autotransfusion
Applicant DEKNATEL, INC. 2300 MARCUS AVE. Lake Success,  NY  11042
ContactRichard J Larkin
CorrespondentRichard J Larkin
DEKNATEL, INC. 2300 MARCUS AVE. Lake Success,  NY  11042
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-21
Decision Date1988-10-13

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