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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Microbial
510(k) Number K170505
Device Name SecurePortIV Catheter Securement Adhesive
Applicant
Adhezion Biomedical, LLC
One Meridian Blvd- Suite 1b02
Wyoming,  PA  19610
Applicant Contact Richard G. Jones
Correspondent
Adhezion Biomedical, LLC
One Meridian Blvd- Suite 1b02
Wyoming,  PA  19610
Correspondent Contact Richard G. Jones
Regulation Number878.4370
Classification Product Code
NZP  
Date Received02/21/2017
Decision Date 09/29/2017
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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