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FDA 510(k) Application Details - K020542
Device Classification Name
Warmer, Peritoneal Dialysate
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510(K) Number
K020542
Device Name
Warmer, Peritoneal Dialysate
Applicant
STICKMAN INDUSTRIES INC.
320 LANARK AVENUE
OTTAWA, ONTARIO K1Z 6R5 CA
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Contact
JEAN CLERMONT
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Regulation Number
876.5630
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Classification Product Code
MLW
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Date Received
02/19/2002
Decision Date
09/27/2002
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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