THORA-KLEX CHEST DRAINAGE UNIT

Bottle, Collection, Vacuum

DAVOL, INC.

The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Thora-klex Chest Drainage Unit.

Pre-market Notification Details

Device IDK896127
510k NumberK896127
Device Name:THORA-KLEX CHEST DRAINAGE UNIT
ClassificationBottle, Collection, Vacuum
Applicant DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston,  RI  02920
ContactAnnette M Fagnant
CorrespondentAnnette M Fagnant
DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston,  RI  02920
Product CodeKDQ  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-23
Decision Date1990-01-24

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