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FDA 510(k) Application Details - K011793
Device Classification Name
Angioscope
More FDA Info for this Device
510(K) Number
K011793
Device Name
Angioscope
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
Other 510(k) Applications for this Company
Contact
JAMES A LEE
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
LYK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/08/2001
Decision Date
04/17/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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