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FDA 510(k) Application Details - K083840
Device Classification Name
Endoscope, Rigid
More FDA Info for this Device
510(K) Number
K083840
Device Name
Endoscope, Rigid
Applicant
MSI MEDSERV INTERNATIONAL DEUTSCHLAND GMBH
ESCAD-STR 3
PFULLENDORF D-88630 DE
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Contact
CHRISTINE STROBEL
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
GCM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/24/2008
Decision Date
09/28/2009
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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