FDA 510(k) Application Details - K061853

Device Classification Name	Prosthesis, Partial Ossicular Replacement   More FDA Info for this Device
510(K) Number	K061853
Device Name	Prosthesis, Partial Ossicular Replacement
Applicant	Grace Medical, Inc. 8500 WOLF LAKE DR., STE. 110 MEMPHIS, TN 38133 US Other 510(k) Applications for this Company
Contact	JEFF COBB 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	06/30/2006
Decision Date	08/18/2006
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