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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 K192802
Device Name primeMidline Catheters
Applicant
Pfm Medical, Inc.
1916 Palomar Oaks Way Suite 150
Carlsbad,  CA  92008
Applicant Contact Mina Jiang
Correspondent
Pfm Medical, Inc.
1916 Palomar Oaks Way Suite 150
Carlsbad,  CA  92008
Correspondent Contact Mina Jiang
Regulation Number880.5200
Classification Product Code
PND  
Date Received09/30/2019
Decision Date 10/28/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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