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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Air Filter Portable Apparatus
510(k) Number K163455
Device Name SurgiCube
Applicant
Surgicube International B.V.
Seggelant-Noord 4
Vierpolders,  NL 3237 MG
Applicant Contact GER VIJFVINKEL
Correspondent
Surgicube International B.V.
Seggelant-Noord 4
Vierpolders,  NL 3237 MG
Correspondent Contact GER VIJFVINKEL
Regulation Number878.5070
Classification Product Code
ORC  
Date Received12/09/2016
Decision Date 09/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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