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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 K892915
Device Name PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION
Applicant
Deknatel, Inc.
Kilometer 9 Carretera
San Jose-Heredia,  CR
Applicant Contact HARRY SAVARD
Correspondent
Deknatel, Inc.
Kilometer 9 Carretera
San Jose-Heredia,  CR
Correspondent Contact HARRY SAVARD
Regulation Number880.6740
Classification Product Code
KDQ  
Date Received04/20/1989
Decision Date 06/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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