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FDA 510(k) Application Details - K972979
Device Classification Name
Cystourethroscope
More FDA Info for this Device
510(K) Number
K972979
Device Name
Cystourethroscope
Applicant
SMITH & NEPHEW, INC.
160 DASCOMB RD.
ANDOVER, MA 01810 US
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Contact
DEBORAH J CONNORS
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
FBO
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More FDA Info for this Product Code
Date Received
08/11/1997
Decision Date
12/11/1997
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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