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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K200425
Device Name Female Luer Lock Cap
Applicant
MedSafety Solutions LLC
7012 S. Revere Pkwy, Suite 120
centennial,  CO  80112
Applicant Contact rich weiskopf
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
saint paul,  MN  55114
Correspondent Contact prithul bom
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/20/2020
Decision Date 10/29/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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