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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bottle, Collection, Vacuum
510(k) Number K962856
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
Applicant
DEKNATEL, INC.
600 AIRPORT ROAD, P.O. BOX
2980
FALL RIVER,  MA  02722 -2980
Applicant Contact DEAN E CIPORKIN
Correspondent
DEKNATEL, INC.
600 AIRPORT ROAD, P.O. BOX
2980
FALL RIVER,  MA  02722 -2980
Correspondent Contact DEAN E CIPORKIN
Regulation Number880.6740
Classification Product Code
KDQ  
Date Received07/22/1996
Decision Date 08/28/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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