FDA 510(k) Application Details - K981575

Device Classification Name	Tube, Tympanostomy   More FDA Info for this Device
510(K) Number	K981575
Device Name	Tube, Tympanostomy
Applicant	Grace Medical, Inc. 7715 HWY. 70, SUITE 109 BARTLETT, TN 38133 US Other 510(k) Applications for this Company
Contact	ANTHONY D PRESCOTT 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	05/04/1998
Decision Date	07/15/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review