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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 K896697
Device Name PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI
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 Received11/28/1989
Decision Date 02/08/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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