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FDA 510(k) Application Details - K970892
Device Classification Name
Cystoscope And Accessories, Flexible/Rigid
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510(K) Number
K970892
Device Name
Cystoscope And Accessories, Flexible/Rigid
Applicant
FIEGERT, INC.
TWO OAKWOOD BLVD. SUITE 160
HOLLYWOOD, FL 33020 US
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Contact
ERNESTO HERNANDEZ
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Regulation Number
876.1500
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Classification Product Code
FAJ
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Date Received
03/11/1997
Decision Date
05/05/1997
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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