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FDA 510(k) Application Details - K150248
Device Classification Name
Laryngoscope, Nasopharyngoscope
More FDA Info for this Device
510(K) Number
K150248
Device Name
Laryngoscope, Nasopharyngoscope
Applicant
JEDMED INSTRUMENT COMPANY
5416 JEDMED COURT
ST. LOUIS, MO 63129 US
Other 510(k) Applications for this Company
Contact
CRAIG PARKS
Other 510(k) Applications for this Contact
Regulation Number
874.4760
More FDA Info for this Regulation Number
Classification Product Code
EQN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/03/2015
Decision Date
07/23/2015
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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