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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 Rd., P.O. Box
2980
Fall River,  MA  02722 -2980
Applicant Contact DEAN E CIPORKIN
Correspondent
Deknatel, Inc.
600 Airport Rd., 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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