FDA 510(k) Application Details - K993212

Device Classification Name Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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510(K) Number K993212
Device Name Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant DIASOL, INC.
13212 RAYMER ST.
NORTH HOLLYWOOD, CA 91605 US
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Contact MONICA ABELES
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Regulation Number 876.5820

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Classification Product Code KPO
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Date Received 09/24/1999
Decision Date 10/22/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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