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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, ward use, portable, ac-powered
510(k) Number K103535
Device Name VACPLUS SUCTION UNIT
Applicant
APEX MEDICAL CORP.
NO.8, LANE 29, WENMING RD.
GUISAN, TAOYUAN,  TW 33383
Correspondent
APEX MEDICAL CORP.
NO.8, LANE 29, WENMING RD.
GUISAN, TAOYUAN,  TW 33383
Regulation Number878.4780
Classification Product Code
JCX  
Date Received12/01/2010
Decision Date 02/24/2011
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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