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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name intravenous catheter force-activated separation device.
De Novo Number DEN190043
Device Name SafeBreak Vascular
Requester
site saver, inc. d/b/a lineus medical
179 n. church ave, suite 202
fayetteville,  AR  72701
Contact lemuel v. clement
Regulation Number880.5220
Classification Product Code
QOI  
Date Received09/18/2019
Decision Date 05/27/2021
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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