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FDA 510(k) Application Details - K193502
Device Classification Name
More FDA Info for this Device
510(K) Number
K193502
Device Name
TGS Universal Headrest with Mounting Arm
Applicant
Stryker ENT
3600 Holly Lane North, Suite 40
Plymouth, MN 55447 US
Other 510(k) Applications for this Company
Contact
Denise Thompson
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PGW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/18/2019
Decision Date
02/14/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
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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