FDA 510(k) Application Details - K963752

Device Classification Name	Prosthesis, Partial Ossicular Replacement   More FDA Info for this Device
510(K) Number	K963752
Device Name	Prosthesis, Partial Ossicular Replacement
Applicant	Grace Medical, Inc. 8624 NORTH LAKE COVE ARLINGTON, TN 38002 US Other 510(k) Applications for this Company
Contact	ANTHONY D PRESCOTT 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	09/18/1996
Decision Date	10/10/1996
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