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FDA 510(k) Application Details - K950712
Device Classification Name
Endoscope, Rigid
More FDA Info for this Device
510(K) Number
K950712
Device Name
Endoscope, Rigid
Applicant
LASER-OPTIK-SYSTEME GMBH & CO. KG
AM SAGEWERK 11
MAINZ 55124 DE
Other 510(k) Applications for this Company
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
02/14/1995
Decision Date
05/14/1996
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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