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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.
#8, Ln. 29, Wenming Rd.
Guisan, Taoyuan,  TW 33383
Correspondent
Apex Medical Corp.
#8, Ln. 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
Predetermined Change
Control Plan Authorized		 No
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