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FDA 510(k) Application Details - K991003
Device Classification Name
Connector, Tubing, Dialysate
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510(K) Number
K991003
Device Name
Connector, Tubing, Dialysate
Applicant
DAYSPRING MEDICAL, INC.
1936 BEACON CT.
BOULDER, CO 80302 US
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Contact
NEIL RASMUSSEN
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Regulation Number
876.5820
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Classification Product Code
FKY
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More FDA Info for this Product Code
Date Received
03/25/1999
Decision Date
06/09/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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