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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 K920819
Device Name ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN
Applicant
Astra Meditec AB
P.O. Box 14
S-4321 21 Molndal
Sweden,  SE
Applicant Contact GOSTA WENNERSTORM
Correspondent
Astra Meditec AB
P.O. Box 14
S-4321 21 Molndal
Sweden,  SE
Correspondent Contact GOSTA WENNERSTORM
Regulation Number878.4680
Classification Product Code
GCY  
Date Received02/24/1992
Decision Date 03/24/1993
Decision Substantially Equivalent - Kit (SESK)
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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