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FDA 510(k) Application Details - K961026
Device Classification Name
Dialyzer, Capillary, Hollow Fiber
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510(K) Number
K961026
Device Name
Dialyzer, Capillary, Hollow Fiber
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
FJI
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More FDA Info for this Product Code
Date Received
03/14/1996
Decision Date
06/10/1996
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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