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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, # 4
08185 Llissa De Vall
Barcelona, Spain,  ES
Applicant Contact LOPEZ RODRIGUEZ
Correspondent
Iberhospitex, S.A.
Avenida De Catalunya, # 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
Predetermined Change
Control Plan Authorized		 No
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