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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, portable, aspiration (manual or powered)
510(k) Number K092903
Device Name BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING
Applicant
MAQUET GMBH AND CO. KG
KEHLER STRASSE 31
RASTATT,  DE 76437
Applicant Contact ANNETTE JAKOB
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number878.4780
Classification Product Code
BTA  
Date Received09/21/2009
Decision Date 12/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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