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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialyzer, capillary, hollow fiber
510(k) Number K961026
Device Name BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL
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
FJI  
Date Received03/14/1996
Decision Date 06/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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