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FDA 510(k) Application Details - K160766
Device Classification Name
Cystoscope And Accessories, Flexible/Rigid
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510(K) Number
K160766
Device Name
Cystoscope And Accessories, Flexible/Rigid
Applicant
AMBU A/S
BALTORPBAKKEN 13
BALLERUP DK-2750 DK
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Contact
CAMILLA WISMAR
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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
03/21/2016
Decision Date
08/17/2016
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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