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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
Applicant
Suzric Enterprise Co., Ltd.
# 77, Keji 2st Rd.
Guishan Township
Taoyuan County,  TW 333
Applicant Contact MICHAEL LEE
Correspondent
Suzric Enterprise Co., Ltd.
# 77, Keji 2st Rd.
Guishan Township
Taoyuan County,  TW 333
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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