FDA 510(k) Application Details - K945105

Device Classification Name	Prosthesis, Partial Ossicular Replacement   More FDA Info for this Device
510(K) Number	K945105
Device Name	Prosthesis, Partial Ossicular Replacement
Applicant	MICROMED DEVELOPMENT CORP. 4911 CREEKSIDE DR. CLEARWATER, FL 34620 US Other 510(k) Applications for this Company
Contact	DAN H TREACE Other 510(k) Applications for this Contact
Regulation Number	874.3450   More FDA Info for this Regulation Number
Classification Product Code	ETB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/1994
Decision Date	05/14/1996
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