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FDA 510(k) Application Details - K131131
Device Classification Name
Esophagoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K131131
Device Name
Esophagoscope (Flexible Or Rigid)
Applicant
INTROMEDIC CO., LTD
3550 WILSHIRE BLVD #738
LOS ANGELES, CA 90010-2401 US
Other 510(k) Applications for this Company
Contact
STEVE KWON
Other 510(k) Applications for this Contact
Regulation Number
874.4710
More FDA Info for this Regulation Number
Classification Product Code
EOX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/22/2013
Decision Date
06/21/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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