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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name negative pressure wound therapy powered suction pump
510(k) Number K112853
Device Name VOLTERA POWERED SUCTION PUMP
Original Applicant
SUZRIC ENTERPRISE CO., LTD.
no. 77, keji 2st road
guishan township
taoyuan county,  TW 333
Original Contact michael lee
Regulation Number878.4780
Classification Product Code
OMP  
Date Received09/29/2011
Decision Date 11/09/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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