FDA 510(k) Application Details - K955616

Device Classification Name	Tube, Tympanostomy   More FDA Info for this Device
510(K) Number	K955616
Device Name	Tube, Tympanostomy
Applicant	MISTEN MEDICAL CORP. 7220 STOUT RD. GERMANTOWN, TN 38138 US Other 510(k) Applications for this Company
Contact	GEORGE W MURRAY 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	12/11/1995
Decision Date	01/17/1996
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