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FDA 510(k) Application Details - K972579
Device Classification Name
Set, Administration, For Peritoneal Dialysis, Disposable
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510(K) Number
K972579
Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK, IL 60085 US
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DAVID C ROSS
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Regulation Number
876.5630
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Classification Product Code
KDJ
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Date Received
07/10/1997
Decision Date
10/01/1997
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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