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FDA 510(k) Application Details - K012374
Device Classification Name
Catheter, Urethral
More FDA Info for this Device
510(K) Number
K012374
Device Name
Catheter, Urethral
Applicant
ASTRA TECH, INC.
96 WEST MAIN ST.
NORTHBOROUGH, MA 01532 US
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Contact
BRUCE R MANNING
Other 510(k) Applications for this Contact
Regulation Number
876.5130
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Classification Product Code
GBM
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More FDA Info for this Product Code
Date Received
07/26/2001
Decision Date
08/23/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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