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FDA 510(k) Application Details - K001362
Device Classification Name
Laryngoscope, Endoscope
More FDA Info for this Device
510(K) Number
K001362
Device Name
Laryngoscope, Endoscope
Applicant
KARL STORZ IMAGING, INC.
175 CREMONA DR.
GOLETA, CA 93117 US
Other 510(k) Applications for this Company
Contact
TERRY FERNANDEZ
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
GCI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/28/2000
Decision Date
07/17/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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