PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR

Bottle, Collection, Vacuum

DEKNATEL, INC.

The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Pleur-evac Sahara Adult/pediatric Chest Drainage System Model S-1100, S-1200, 2-2100, And S-2200 With Model S-100 Autotr.

Pre-market Notification Details

Device IDK962856
510k NumberK962856
Device Name:PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
ClassificationBottle, Collection, Vacuum
Applicant DEKNATEL, INC. 600 AIRPORT ROAD, P.O. BOX 2980 Fall River,  MA  02722 -2980
ContactDean E Ciporkin
CorrespondentDean E Ciporkin
DEKNATEL, INC. 600 AIRPORT ROAD, P.O. BOX 2980 Fall River,  MA  02722 -2980
Product CodeKDQ  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-22
Decision Date1996-08-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
44026704607363 K962856 000
44026704428906 K962856 000
14026704631725 K962856 000
14026704631664 K962856 000
34026704921899 K962856 000

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