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FDA 510(k) Application Details - K960787
Device Classification Name
System, Irrigation, Urological
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510(K) Number
K960787
Device Name
System, Irrigation, Urological
Applicant
BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE, IL 60073 US
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Contact
MARY-ELLEN SAYDER
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Regulation Number
000.0000
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Classification Product Code
LJH
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Date Received
02/26/1996
Decision Date
05/14/1996
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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