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FDA 510(k) Application Details - K202957
Device Classification Name
Cystoscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K202957
Device Name
Cystoscope And Accessories, Flexible/Rigid
Applicant
KARL STORZ Endoscopy-America, Inc
2151 E. Grand Avenue
EI Segundo, CA 90245 US
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Contact
Winkie Wong
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
09/30/2020
Decision Date
10/29/2020
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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