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FDA 510(k) Application Details - K955277
Device Classification Name
Accessories, Blood Circuit, Hemodialysis
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510(K) Number
K955277
Device Name
Accessories, Blood Circuit, Hemodialysis
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK, IL 60085 US
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Contact
ROBERT L WILKINSON
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Regulation Number
876.5820
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Classification Product Code
KOC
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More FDA Info for this Product Code
Date Received
11/17/1995
Decision Date
02/16/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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