FDA 510(k) Application Details - K011942

Device Classification Name	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented   More FDA Info for this Device
510(K) Number	K011942
Device Name	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant	TORNIER RUE DOYEN GOSSE ST. ISMIER 38330 FR Other 510(k) Applications for this Company
Contact	IRENE GOSSET Other 510(k) Applications for this Contact
Regulation Number	888.3690   More FDA Info for this Regulation Number
Classification Product Code	HSD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2001
Decision Date	07/13/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review