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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, suction, single patient use, portable, nonpowered
510(k) Number K883982
Device Name DRENOVAC
Applicant
IBERHOSPITEX, S.A.
AVENIDA DE CATALUNYA, NO. 4
08185 LLISSA DE VALL
BARCELONA, SPAIN,  ES
Applicant Contact LOPEZ RODRIGUEZ
Correspondent
IBERHOSPITEX, S.A.
AVENIDA DE CATALUNYA, NO. 4
08185 LLISSA DE VALL
BARCELONA, SPAIN,  ES
Correspondent Contact LOPEZ RODRIGUEZ
Regulation Number878.4680
Classification Product Code
GCY  
Date Received09/20/1988
Decision Date 02/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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