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FDA 510(k) Application Details - K012153
Device Classification Name
Catheter, Suprapubic (And Accessories)
More FDA Info for this Device
510(K) Number
K012153
Device Name
Catheter, Suprapubic (And Accessories)
Applicant
CIRCON VIDEO
6500 HOLLISTER AVE.
SANTA BARBARA, CA 93117-3019 US
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Contact
WAYNE B STGRNER
Other 510(k) Applications for this Contact
Regulation Number
876.5090
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Classification Product Code
KOB
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More FDA Info for this Product Code
Date Received
07/11/2001
Decision Date
09/19/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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