FDA 510(k) Application Details - K043375

Device Classification Name	Replacement, Ossicular Prosthesis, Total   More FDA Info for this Device
510(K) Number	K043375
Device Name	Replacement, Ossicular Prosthesis, Total
Applicant	KARL STORZ ENDOSCOPY 600 CORPORATE POINTE 5TH FLOOR CULVER CITY, CA 90230-7600 US Other 510(k) Applications for this Company
Contact	YVONNE FERNANDEZ Other 510(k) Applications for this Contact
Regulation Number	874.3495   More FDA Info for this Regulation Number
Classification Product Code	ETA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2004
Decision Date	01/24/2005
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