FDA 510(k) Application Details - K151830

Device Classification Name	Tube, Tympanostomy   More FDA Info for this Device
510(K) Number	K151830
Device Name	Tube, Tympanostomy
Applicant	PRECEPTIS MEDICAL 505 HIGHWAY 169 NORTH, #365 PLYMOUTH, MN 55441 US Other 510(k) Applications for this Company
Contact	Keith Leland Other 510(k) Applications for this Contact
Regulation Number	874.3880   More FDA Info for this Regulation Number
Classification Product Code	ETD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2015
Decision Date	09/21/2015
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