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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, for peritoneal dialysis, disposable
510(k) Number K151620
Device Name Firefly Peritoneal Dialysis Connector Disinfection System
Applicant
PURACATH MEDICAL, INC.
660 4TH STREET #104
SAN FRANCISCO,  CA  94107
Applicant Contact JOHN ASHLEY
Correspondent
PURACATH MEDICAL, INC.
660 4TH STREET #104
SAN FRANCISCO,  CA  94107
Correspondent Contact JOHN ASHLEY
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received06/16/2015
Decision Date 01/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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