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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 K093241
Device Name V7 PORTABLE SUCTION UNITS
Applicant
HERSILL, S.L.
PUERTO DE NAVACERRADA, 3
MOSTOLES ( MADRID),  ES 28935
Applicant Contact OSCAR JORDAN
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact JEFF RONGERO
Regulation Number878.4780
Classification Product Code
BTA  
Date Received10/15/2009
Decision Date 04/27/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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