FDA 510(k) Application Details - K991005

Device Classification Name System, Blood, Extracorporeal And Accessories

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510(K) Number K991005
Device Name System, Blood, Extracorporeal And Accessories
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 LLB
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Date Received 03/25/1999
Decision Date 06/22/1999
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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