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FDA 510(k) Application Details - K983010
Device Classification Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter
More FDA Info for this Device
510(K) Number
K983010
Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter
Applicant
RUSCH INTL.
TALL PINES PARK
JAFFREY, NH 03452 US
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Contact
KARENANN J BROZOWSKI
Other 510(k) Applications for this Contact
Regulation Number
876.5130
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Classification Product Code
FCM
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More FDA Info for this Product Code
Date Received
08/28/1998
Decision Date
02/12/1999
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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