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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Midline Catheter
510(k) Number K181208
Device Name Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter
Applicant
Vygon USA
2750 Morris Rd.
Suite A200
Lansdale,  PA  19460
Applicant Contact Jillian Mikovich
Correspondent
Vygon USA
2750 Morris Rd.
Suite A200
Lansdale,  PA  19460
Correspondent Contact Jillian Mikovich
Regulation Number880.5200
Classification Product Code
PND  
Date Received05/07/2018
Decision Date 11/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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