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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Tubing, Dialysate
510(k) Number K991003
Device Name PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI
Applicant
DAYSPRING MEDICAL, INC.
1936 BEACON CT.
BOULDER,  CO  80302
Applicant Contact NEIL RASMUSSEN
Correspondent
DAYSPRING MEDICAL, INC.
1936 BEACON CT.
BOULDER,  CO  80302
Correspondent Contact NEIL RASMUSSEN
Regulation Number876.5820
Classification Product Code
FKY  
Date Received03/25/1999
Decision Date 06/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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