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FDA 510(k) Application Details - K982620
Device Classification Name
Cystoscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K982620
Device Name
Cystoscope And Accessories, Flexible/Rigid
Applicant
MEDIVISION SCOPE SERVICE CENTER, INC.
1440 SOUTH STATE COLLEGE BLVD.
SUITE 1C
ANAHEIM, CA 92806 US
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Contact
WAYNE B STERNER
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
FAJ
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More FDA Info for this Product Code
Date Received
07/27/1998
Decision Date
09/30/1998
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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