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FDA 510(k) Application Details - K993330
Device Classification Name
Warmer, Peritoneal Dialysate
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510(K) Number
K993330
Device Name
Warmer, Peritoneal Dialysate
Applicant
HEMOCLEANSE, INC.
2700 KENT AVE.
WEST LAFAYETTE, IN 47906 US
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Contact
STEPHEN R ASH
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Regulation Number
876.5630
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Classification Product Code
MLW
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Date Received
10/04/1999
Decision Date
12/30/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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