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FDA 510(k) Application Details - K142695
Device Classification Name
Esophagoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K142695
Device Name
Esophagoscope (Flexible Or Rigid)
Applicant
Covidien LLC
15 HAMPSHIRE ST
MANSFIELD, MA 02048 US
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Contact
Richelle Hover
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
09/22/2014
Decision Date
11/26/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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